MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR

Ventilator, High Frequency

FDA Premarket Approval P850064 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Premarket approval (pma) // quick links: skip to main page content skip to search skip to topics menu skip to common links u. S. Food & drug administration follow fda en español search fda home food drugs medical devices radiation-emitting products vaccines, blood & biologics animal & veterinary cosmetics tobacco products premarket approval (pma) 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; } }; 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" } ; fda home medical devices databases -. Pma { color: #000000; width: 900px; float: right; margin: 0px 25px 0px 0px; }. Pma-left { color: #000000; float: left; width: 610px; margin: 9px 30px 0px 0; }. Pma-right { color: #000000; float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; }. Pma-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #pma-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #pma-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #pma-form-title-left { font-size: 13px; font-weight: bold; } #pma-form-title-right { font-size: 11px; padding: 0px 0px 0px 300px; } #pma-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #pma-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #pma-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #pma-results-table tr:nth-child(odd) { background-color: #f3f3f3; }. Sort { float: right; margin-top: 5px;}. Sort a { color: #484138; }. Sort a:hover { color: #0f2a8c; }

DeviceMODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
Classification NameVentilator, High Frequency
Generic NameVentilator, High Frequency
ApplicantBUNNELL, INC.
Date Received1988-09-19
Decision Date1989-02-02
PMAP850064
SupplementS001
Product CodeLSZ
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115

Supplemental Filings

Supplement NumberDateSupplement Type
P850064Original Filing
S047 2022-03-07 30-day Notice
S046 2021-05-27 30-day Notice
S045
S044 2021-01-28 30-day Notice
S043 2020-10-29 30-day Notice
S042 2019-11-15 30-day Notice
S041 2019-10-24 30-day Notice
S040
S039 2019-02-27 135 Review Track For 30-day Notice
S038 2018-10-25 30-day Notice
S037 2018-09-20 30-day Notice
S036 2018-01-29 Real-time Process
S035 2017-10-02 Real-time Process
S034 2017-06-07 30-day Notice
S033 2016-07-22 30-day Notice
S032 2016-05-24 Real-time Process
S031 2016-02-24 Real-time Process
S030 2015-03-31 Normal 180 Day Track
S029 2015-02-18 30-day Notice
S028 2015-02-04 Normal 180 Day Track
S027 2014-08-25 Normal 180 Day Track No User Fee
S026 2014-01-27 30-day Notice
S025 2013-09-09 30-day Notice
S024
S023 2013-06-10 Normal 180 Day Track
S022
S021 2012-09-07 Normal 180 Day Track
S020
S019
S018 2010-02-22 Normal 180 Day Track
S017 2001-04-04 Normal 180 Day Track
S016 1999-09-10 Special (immediate Track)
S015 1998-10-21 Normal 180 Day Track
S014 1998-08-28 Special (immediate Track)
S013
S012 1997-04-11 Special (immediate Track)
S011 1995-04-05 Normal 180 Day Track
S010 1994-08-05 Normal 180 Day Track
S009 1992-11-27 Normal 180 Day Track
S008
S007
S006 1991-08-01 Normal 180 Day Track
S005 1990-10-01 Normal 180 Day Track
S004
S003 1989-07-24 Normal 180 Day Track
S002 1989-02-09 Normal 180 Day Track
S001 1988-09-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10616120000089 P850064 000
00616120000020 P850064 000
00616120000006 P850064 000
00616120000013 P850064 017
00616120000112 P850064 028
00616120000105 P850064 028

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