Product Classification

<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3c.org/TR/1999/REC-html401-19991224/loose.dtd"> <html xmlns="http://www.w3.org/1999/xhtml" xmlns:addthis="http://www.addthis.com/help/api-spec"> <head> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <meta http-equiv="X-UA-Compatible" content="IE=7" /> <script type="text/javascript" src="/scripts/includes/js/wcm.toggle.js"></script> <script type="text/javascript" src="/scripts/includes/js/ssajax_2012.js"></script> <title>Product Classification</title>  <link href="/scripts/cdrh/cfdocs/default_style.css" rel="stylesheet" media="all" type="text/css" /> <link rel="stylesheet" type="text/css" media="screen" href="/scripts/includes/css/css_fda_gov_stylesheet-2013.css" /> <link rel="stylesheet" type="text/css" media="print" href="/scripts/includes/css/css_fda_gov_print_stylesheet-2013.css" />   <script type="text/javascript" src="/scripts/includes/js/js_jquery_142.js" language="JavaScript"></script>  <script type="text/javascript" src="/scripts/includes/js/js_fdagov_global.js" language="JavaScript"></script>       <script type="text/javascript" src="/scripts/includes/js/js_fdagov_resize.js"></script>     <meta name="dc.title" content="Product Classification" /> <meta name="dc.type" content="" /> <meta name="dc.description" content="" /> <meta name="dc.language" content="" /> <meta name="posted" content="" /> <meta name="Keywords" content="" /> <meta name="Description" content="" /> <meta name="dc.subject" content="" /> <meta name="dc.publisher" content="" /> <meta name="dc.audience" content="" /> <meta name="dc.creator" content="" /> <meta name="search_topic" content=""/> <meta name="google-site-verification" content="wxQkNTrqmvYnwVcNzA2mspBp7EDErzIhAzyX-YvvRWI" /> <script>(function(i,s,o,g,r,a,m){i['GoogleAnalyticsObject1']=r;i[r]=i[r]||function(){ (i[r].q=i[r].q||[]).push(arguments)},i[r].l=1*new Date();a=s.createElement(o), m=s.getElementsByTagName(o)[0];a.async=1;a.src=g;m.parentNode.insertBefore(a,m) })(window,document,'script','https://www.googletagmanager.com/gtag/js?id=G-B0V4T2XCW7','gtag'); window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-B0V4T2XCW7');</script> </head> <body>  <script language="javascript" id="_fed_an_ua_tag" src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true"></script>  <div class="quicklinks"> <a href="#main" accesskey="2" class="quicklinks" tabindex="1" title="Skip to content">Quick Links: Skip to main page content</a> <a href="#search_form" class="quicklinks" tabindex="1" title="Skip to search">Skip to Search</a> <a href="#fda-topmenu-home" class="quicklinks" tabindex="1" title="Skip to FDA top menu">Skip to Topics Menu</a> <a href="#footer" class="quicklinks" tabindex="1" title="Skip to site options">Skip to Common Links</a> </div>  <div id="outerwrapper">   <MAXAMINEIGNORE XMLNS="FDA"> <div id="hhs-masthead">   <div id="hhs-rightmast">  <div id="page-tools"> <ul class="list-horizontal"> <li><a id="font-size-decrease" href="#" title="Decrease font size"><img src="/scripts/includes/images/img_fdagov_font_adj_small.png" alt="Decrease font size" title="Decrease font size"/></a></li> <li><a id="font-size-standard" href="#" title="Return font size to normal"><img src="/scripts/includes/images/img_fdagov_font_adj_medium.png" alt="Return font size to normal" title="Return font size to normal"/></a></li> <li><a id="font-size-increase" href="#" title="Increase font size"><img src="/scripts/includes/images/img_fdagov_font_adj_large.png" alt="Increase font size" title="Increase font size"/></a></li </ul> </div>  </div>   <div id="hhs-leftmast"> <a href="http://www.hhs.gov/" title="U.S. Department of Health and Human Services"><img id="rrimg1" border="0" src="/scripts/includes/images/img_fdagov_hhs_masthead_logo_r.png" alt="U.S. Department of Health and Human Services" title="U.S. Department of Health and Human Services"/></a> </div>  </div> <div id="wrapper">  <div id="header">  <div id="fda-masthead">  <div id="fda-leftmast"> <div id="FDAlogo"> <a href="https://www.fda.gov/" title="FDA, U.S. Food and Drug Administration"><img src="/scripts/includes/images/gov-fda-new-white.png" alt="FDA, U.S. Food and Drug Administration" border="0" title="FDA, U.S. Food and Drug Administration"/></a> </div>  <div class="print-pagetitle"> U.S. Food & Drug Administration </div>  <div class="clearfloat"> </div> </div>   <div id="fda-rightmast">  <div id="masthead-links"> <ul class="list-horizontal"> <li><a href="https://www.fda.gov/news-events/interactive-media" title="Follow FDA">Follow FDA</a></li> <li class="last"><a title="En Español" href="https://www.fda.gov/about-fda/fda-en-espanol">En Español</a></li> </ul> </div>  <div id="search-form"> <form id="search_form" action="https://www.fda.gov/search" accept-charset="UTF-8" method="get"> <label class="searchlable" for="query">Search FDA</label> <input accesskey="4" type="text" name="s" id="query" autocomplete="off" class="usagov-search-autocomplete" /> <div id="go_button" style="left:150px"> <a href="javascript:document.getElementById('search_form').submit();" title="Search this site"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"/></a> </div> </form> <div class="clearfloat"> </div> </div> </div>  </div> </MAXAMINEIGNORE> <div id="fda-topmenu"> <ul class="menu-tabbed"> <li><a id="fda-topmenu-home" title="Home" href="https://www.fda.gov/" accesskey="1"><span>Home</span></a></li> <li><a title="Food" href="https://www.fda.gov/food"><span>Food</span></a></li> <li><a title="Drugs" href="https://www.fda.gov/Drugs"><span>Drugs</span></a></li> <li><a title="Medical Devices" href="https://www.fda.gov/Medical-Devices"><span>Medical Devices</span></a></li> <li><a title="Radiation-Emitting Products" href="https://www.fda.gov/radiation-emitting-products"><span>Radiation-Emitting Products</span></a></li> <li><a title="Vaccines, Blood and Biologics" href="https://www.fda.gov/vaccines-blood-biologics"><span>Vaccines, Blood & Biologics</span></a></li> <li class=""><a title="Animal and Veterinary" href="https://www.fda.gov/animal-veterinary"><span>Animal & Veterinary</span></a></li> <li><a title="Cosmetics" href="https://www.fda.gov/cosmetics"><span>Cosmetics</span></a></li> <li><a title="Tobacco Products" href="https://www.fda.gov/tobacco-products"><span>Tobacco Products</span></a></li> </ul> </div> <div class="clearfloat"> </div> </div>  <div id="content"> <div class="clearfloat"> </div> <div class="clearfloat"> </div>  <span id="pageTitleHolder"><h1 id="topic_page_title" class="head1">Product Classification</h1></span>   <div id="page-options" class="hover-fade"> <ul class="list-horizontal"> <li><a href="javascript:window.print();" title="Print this page"><img src="/scripts/includes/images/img_fdagov_utility_icon_print.png" alt="Print" title="Print this page"/></a></li> <li><a href="http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain" class="addthis_button_compact" title="Share this page"><img src="/scripts/includes/images/img_fdagov_utility_icon_share.png" alt="Share" title="Share this page"/></a></li> <li><a href="http://www.addthis.com/bookmark.php" class="addthis_button_email" title="E-mail this page"><img src="/scripts/includes/images/img_fdagov_utility_icon_email.png" alt="E-mail" title="E-mail this page"/></a></li> </ul>  <script language="JavaScript" type="text/javascript"> var MP = {  Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en',  UrlLang: 'mp_js_current_lang', SrcUrl: unescape('mp_js_orgin_url'),  init: function(){ if (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, getCookie: function(name){ var start=document.cookie.indexOf(name+'='); if(start < 0) return null; start=start+name.length+1; var end=document.cookie.indexOf(';', start); if(end < 0) end=document.cookie.length; while (document.cookie.charAt(start)==' '){ start++; } return unescape(document.cookie.substring(start,end)); }, setCookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new Date(); now.setTime(now.getTime()+1000*60*60*24*365); cookie+='; expires='+now.toUTCString(); document.cookie=cookie; }, switchLanguage: function(lang){ if(lang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); document.body.appendChild(script); } else if(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); document.body.appendChild(script); } return false; }, switchToLang: function(url) { window.top.location.href=url; }  }; </script>  <script type="text/javascript" src="/scripts/includes/js/addthis_widget_2012.js#pub=fdamain"></script> <script type="text/javascript">var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ;</script> </div>   <div id="fda-breadcrumbs">   <div class="hmenu"> <ul class="list-horizontal"> <li><a href="https://www.fda.gov/" id="main">FDA Home</a></li> <li><a href="https://www.fda.gov/Medical-Devices">Medical Devices</a></li> <li><a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases">Databases</a></li> </ul> </div> </div>  <div class="clearfloat"> - </div>      <span id="user_provided"> <style> .pcd { color: #000000; float: center; width: 900px; margin: 10px 10px 10px 10px; } .pcd-left { color: #000000; float: left; width: 610px; margin: 9px 30px 100px 0; } .pcd-right { color: #000000; float: right; width: 210px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .pcd-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #pcd-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #pcd-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #pcd-form-title-left { float: middle; font-size: 13px; font-weight:bold; padding: 0px 0px 0px 0px; } #pcd-form-title-right { font-size: 11px; float: right; } #pcd-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #pcd-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #pcd-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #pcd-results-table tr:nth-child(odd) { background-color: #f3f3f3; } .sort { float: right; margin-top: 5px;} .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } </style> <table border="0" cellpadding="0" cellspacing="0" width="300" align="center" style="font-family: arial; color: #23238e;"> <tr valign="top"> <td bgcolor="#888888"> <table border="0" cellpadding="5" cellspacing="1" width="500"> <tr valign="top"> <td bgcolor="#e9e9e3" width="100%"> <table width="100%" border="0"> <tr> <td align="left"><a href="classification.cfm">New Search</a></td> <td align="right"><a href="javascript: history.go(-1)">Back to Search Results</a></td> </tr> </table> </td> </tr> <tr valign="top"> <td bgcolor="#f9f9f3" align="center"> <table border="0" cellpadding="0" cellspacing="5" width="100%" align="center"> <tr> <td nowrap align="left" width="100%"> <table border="0" cellpadding="0" cellspacing=5 width="600"> <tbody> <tr> <tr style="font-family: arial; color: #23238e;"> <th align="left" style="width:30%">Device</th> <td align="left" style="text-transform: capitalize; width:70%">system, nuclear magnetic resonance imaging</td> </tr> <tr> <th align="left" nowrap>Regulation Description</th> <td align="left">Magnetic resonance diagnostic device.</td> </tr> <tr> <th align="left">Regulation Medical Specialty</th> <td align="left">Radiology</td> </tr> <tr><th align="left">Review Panel</th> <td align="left"> Radiology </td> </tr> <tr><th align="left" nowrap>Product Code</th><td align="left">LNH</td></tr> <tr valign="top"> <th align="left" nowrap>Premarket Review</th> <td align="left"> <A style="text-decoration:underline;" href="https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization#OHT8">Office of Radiological Health</A> (OHT8)<br> Radiological Imaging and Radiation Therapy Devices (DHT8C)<br> </td> </tr> <tr><th align="left" nowrap>Submission Type</th> <td align="left"> 510(k) </td></tr> <tr><th align="left" nowrap>Regulation Number</th> <td align="left"> <a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.1000" title="information about 21cfr892.1000">892.1000</a> </td> </tr> <tr> <th align="left" nowrap>Device Class</th> <td align="left"> 2 </td> </tr> <tr> <th align="left" nowrap>Total Product Life Cycle (TPLC)</th> <td align="left"> <A style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5782">TPLC Product Code Report</A> </td> </tr> <tr> <th align="left" nowrap>GMP Exempt?</th> <td align="left">No </td> </tr> <tr> <th align="left" nowrap>Summary Malfunction<br>Reporting</th> <td align="left">Eligible</td> </tr> <tr><th align="left" nowrap>Implanted Device? </th><td align="left"> No </td></tr> <tr><th align="left" nowrap>Life-Sustain/Support Device? </th><td align="left"> No </td></tr> <tr valign="top"> <td valign="top" align="left" colspan="2"><strong>Recognized Consensus Standards</strong> <table class="hardbreak" cellpadding="0" cellspacing="0" border="0" align="left" style="margin:0 10px; width:100%"> <tr><td><ul><li>12-187 NEMA MS 3-2008 (R2020)<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33531">Determination of Image Uniformity in Diagnostic Magnetic Resonance Images</a></li><li>12-188 NEMA MS-1-2008 (R2020)<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33530">Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging</a></li><li>12-195 NEMA MS 6-2008 (R2014, R2020)<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33533">Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging</a></li><li>12-196 NEMA MS 2-2008 (R2020)<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33534">Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images</a></li><li>12-232 NEMA MS 4-2010<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=45393">Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices</a></li><li>12-264 NEMA MS 11-2010<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32083">Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging</a></li><li>12-288 NEMA MS 9-2008 (R2020)<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33541">Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images</a></li><li>12-292 IEEE Std 3333.2.1-2015 <br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=33222">IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling</a></li><li>12-295 IEC 60601-2-33 Ed. 3.2 b:2015<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44630">Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis</a></li><li>12-298 NEMA MS 10-2010<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=34007">Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging</a></li><li>12-306 NEMA MS 12-2016<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=35654">Quantification and Mapping of Geometric Distortion for Special Applications</a></li><li>12-315 NEMA MS 8-2016<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=37048">Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems</a></li><li>12-322 NEMA MS 5-2018<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=38515">Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging</a></li><li>12-331 NEMA Standards Publication MS 14-2019<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40852">Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems</a></li><li>12-332 IEC 62464-1 Edition 2.0 2018-12<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40830">Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.</a></li><li>12-347 IEC 60601-2-33 Edition 4.0 2022-08 <br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44629">Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis</a></li><li>12-354 NEMA MS 4-2023<br><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=45392">Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices</a></li></ul></td></tr></table> </td></tr> <tr valign="top"> <td valign="top" align="left" colspan="2"><strong>Guidance Documents</strong> <table class="hardbreak" cellpadding="0" cellspacing="0" border="0" align="left" style="margin:0 10px; width:100%"> <tr><td><ul><li><A style="text-decoration:underline;" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/criteria-significant-risk-investigations-magnetic-resonance-diagnostic-devices-guidance-industry-and">Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff</li></ul></td></tr> <tr><td><ul><li><A style="text-decoration:underline;" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-notifications-magnetic-resonance-diagnostic-devices">Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final</li></ul></td></tr> </table> </td> </tr> <tr> <td valign="top" align="left" colspan="2"> <b>Third Party Review</b> <table width="100%" cellpadding="0" cellspacing="0" border="0" align="left" style="margin:0 10px; width:100%"> <tr><td><ul><li>Eligible for <i><a style="text-decoration:underline;" href="https://www.fda.gov/medical-devices/premarket-submissions/510k-third-party-review-program" title="Accredited Persons and Third Party information">510(k) Third Party Review Program</a></i></li></ul></td></tr> </table> </td> </tr> <tr> <td valign="top" align="left" colspan="2"> <b>Accredited Persons</b> <br> <table cellpadding="0" cellspacing="0" border="0" align="left" style="margin:0 10px; width:100%"> <tr><td><ul> <li style="text-transform: capitalize"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key=1#top">beanstock consulting</a></li> <li style="text-transform: capitalize"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key=3#top">center for measurement standards of industrial</a></li> <li style="text-transform: capitalize"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key=11#top">global quality and regulatory services</a></li> <li style="text-transform: capitalize"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key=4#top">regulatory technology services, llc</a></li> <li style="text-transform: capitalize"><a style="text-decoration:underline;" href="/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm?party_key=7#top">third party review group, llc</a></li> </ul> </td></tr></table> </td> </tr> </tbody> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table>  </span> <div class="clearfloat"> - </div> </div> <div class="clearfloat"> - </div>   <script type="text/javascript"> setStyle(); </script>   <div id="footer">  <div id="footnote"><h4>Links on this page:</h4><div></div></div>   <div id="pagetools_bottom"> <div id="pagetools_right"> <p>Page Last Updated: 11/25/2024</p> <p> Note: If you need help accessing information in different file formats, see <a href="https://www.fda.gov/about-fda/website-policies/viewing-files">Instructions for Downloading Viewers and Players</a>. <br>Language Assistance Available: <a title="Spanish" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#spanish">Español</a> | <a title="Chinese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#chinese">繁體中文</a> | <a title="Vietnamese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#vietnamese">Tiếng Việt</a> | <a title="Korean" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#korean">한국어</a> | <a title="Tagolog" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#tagalog">Tagalog</a> | <a title="Russian" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#russian">Русский</a> | <a title="Arabic" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#arabic">العربية</a> | <a title="Creole" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#creole">Kreyòl Ayisyen</a> | <a title="French" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#french">Français</a> | <a title="Polish" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#polish">Polski</a> | <a title="Portuguese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#portuguese">Português</a> | <a title="Italian" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#italian">Italiano</a> | <a title="German" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#german">Deutsch</a> | <a title="Japanese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#japanese">日本語</a> | <a title="Farsi" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#farsi">فارسی</a> | <a title="English" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#english">English</a> </p> </div> <br class="clearfloat" /> </div>  <div id="footer-heading"> <div id="footer-fdalinks"> <ul class="list-horizontal"> <li class="first"><a href="https://www.fda.gov/about-fda/about-website/accessibility" title="Accessibility">Accessibility</a></li> <li><a href="https://www.fda.gov/about-fda/contact-fda" title="Contact FDA">Contact FDA</a></li> <li><a href="https://www.fda.gov/about-fda/jobs-and-training-fda" title="Careers">Careers</a></li> <li><a href="https://www.fda.gov/about-fda/transparency/fda-basics" title="FDA Basics">FDA Basics</a></li> <li><a href="https://www.fda.gov/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.fda.gov/about-fda/jobs-and-training-fda/no-fear-act" title="No FEAR Act">No FEAR Act</a></li> <li><a title="Nondiscrimination" href="https://www.fda.gov/about-fda/about-website/fda-nondiscrimination-notice">Nondiscrimination</a></li> <li class="last"><a href="https://www.fda.gov/about-fda/about-website/website-policies" title="Website Policies">Website Policies / Privacy</a></li> </ul> </div> <div id="footer-fdalogo"> <a href="http://www.fda.gov" title="FDA Homepage"><img src="/scripts/includes/images/fda-square-white-small.png" alt="FDA" title="FDA Homepage"/></a> </div> </div>   <div id="footer-content" class="three-column"> <div id="footer-fda" class="first"> <div class="footer-header">U.S. Food and Drug Administration</div> <div class="address"> 10903 New Hampshire Avenue <br/> Silver Spring, MD 20993 <br/> Ph. 1-888-INFO-FDA (1-888-463-6332)<br/> <a href="https://www.fda.gov/about-fda/contact-fda" title="Contact FDA">Contact FDA</a> </div> <div id="social-links" class="hover-fade"> <ul class="list-horizontal"> <li><a href="http://www.usa.gov" title="USA.gov"><img src="/scripts/includes/images/img_fdagov_footer_logo_usagov.png" alt="USA.gov" title="USA.gov"/></a></li> <li><a href="https://www.fda.gov/about-fda/contact-fda/get-email-updates" title="Subscribe to E-mails"><img src="/scripts/includes/images/img_fdagov_footer_icon_email.png" alt="E-mail" title="Subscribe to E-mails"/></a></li> <li><a href="https://www.fda.gov/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to RSS Feeds"><img src="/scripts/includes/images/img_fdagov_footer_icon_rss.png" alt="RSS" title="Subscribe to RSS Feeds"/></a></li> <li><a href="https://www.fda.gov/news-events/interactive-media#micro" title="Follow FDA on Twitter"><img src="/scripts/includes/images/img_fdagov_footer_icon_twitter.png" alt="Twitter" title="Follow FDA on Twitter"/></a></li> <li><a href="https://www.fda.gov/news-events/interactive-media#Facebook" title="Follow FDA on Facebook"><img src="/scripts/includes/images/img_fdagov_ftr_icon_facebook.png" alt="Facebook" title="Follow FDA on Facebook" /></a></li> <li><a href="http://www.youtube.com/user/USFoodandDrugAdmin" title="View FDA Videos"><img src="/scripts/includes/images/img_fdagov_footer_icon_youtube.png" alt="YouTube" title="View FDA Videos"/></a></li> <li><a href="https://www.fda.gov/news-events/interactive-media#flickr" title="View FDA Photostream on Flickr"><img src="/scripts/includes/images/img_fdagov_footer_icon_flickr.png" alt="Flickr" title="View FDA Photostream on Flickr"></a></li> </ul> </div> <div id="footer-audience"> <ul class="list-horizontal"> <li class="first"><a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials" title="For Government">For Government</a></li> <li class="last"><a href="https://www.fda.gov/news-events" title="For Press">For Press</a></li> </ul> </div> </div> <div id="footer-links" class="second"> <div> <ul class="list-no-bullets"> <li><a href="https://www.fda.gov/combination-products" title="Combination Products">Combination Products</a></li> <li><a href="https://www.fda.gov/advisory-committees" title="Advisory Committees">Advisory Committees</a></li> <li><a href="https://www.fda.gov/Science-Research" title="Science & Research">Science & Research</a></li> <li><a href="https://www.fda.gov/Regulatory-Information" title="Regulatory Information">Regulatory Information</a></li> <li><a href="https://www.fda.gov/Safety" title="Safety">Safety</a></li> <li><a href="https://www.fda.gov/emergency-preparedness-and-response" title="Emergency Preparedness">Emergency Preparedness</a></li> <li><a href="https://www.fda.gov/international-programs" title="International Programs">International Programs</a></li> <li><a href="https://www.fda.gov/news-events" title="News & Events">News & Events</a></li> <li><a href="https://www.fda.gov/training-and-continuing-education" title="Training and Continuing Education">Training and Continuing Education</a></li> <li><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations" title="Inspections/Compliance">Inspections/Compliance</a></li> <li><a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials" title="State & Local Officials">State & Local Officials</a></li> <li><a href="https://www.fda.gov/consumers" title="Consumers">Consumers</a></li> <li><a href="https://www.fda.gov/industry" title="Industry">Industry</a></li> <li><a href="https://www.fda.gov/health-professionals" title="Health Professionals">Health Professionals</a></li> <li><a href="https://www.fda.gov/about-fda/about-website/fdagov-archive" title="FDA Archive">FDA Archive</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" target="_blank">Vulnerability Disclosure Policy</a></li> </ul> </div> </div> <div id="footer-hhs" class="third"> <div class="footer-header"><a href="http://www.hhs.gov" title="U.S. Department of Health & Human Services"><img src="/scripts/includes/images/img_fdagov_footer_hhslogo.png" alt="U.S. Department of Health & Human Services" title="U.S. Department of Health & Human Services"/></a></div> </div> <div class="clearfloat"> </div> </div>   <div id="footnote"><h4>Links on this page:</h4><div></div></div>       </div>  <div class="clearfloat"> </div> </div> <div id="bottom_corner" class="box_bottom"></div> <div class="clearfloat"> </div>  </body> </html>

CINXE.COM

Product Classification