Product code DTE

Product
Radiation Emitting Electronic Codes // 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 De
Definition
Radiation Emitting Electronic Product Codes // 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 Co
Description
Radiation Emitting Electronic Product Codes // 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   Radiation Emitting Electronic Product Codes 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 -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // 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   Radiation Emitting Electronic Product Codes 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 -

Current FDA Classification

Device name
Pulse-Generator, Pacemaker, External
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.3600
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K241781Solo Pace ControlSolo Pace, Inc.2025-01-10
K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2020-05-13
K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2019-04-30
K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2018-08-21
K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc.2018-04-19
K162054Medtronic Temporary External Pacemaker 53401Medtronic, Inc.2016-10-18
K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2016-10-12
K150246Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.2015-02-18
K132924MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)Medtronic, Inc.2013-10-31
K123916PSA SERIESOsypka Medical, Inc.2013-04-09
K042708ERA 3000 PACING SYSTEM ANALYZERBiotronik, Inc.2004-10-20
K033130PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOROsypka Medical, Inc.2003-10-31
K023080GALIX PACESTARGalix Biomedical Instrumentation, Inc.2003-06-11
K022939OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIESOsypka Medical, Inc.2002-10-03
K020896OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENEOsypka Medical, Inc.2002-06-14
K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825Pace Medical2001-09-12
K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VPace Medical2000-10-18
K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528Pace Medical2000-06-27
K970347MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEMPaladin Medical, Inc.1997-08-29
K971474MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOLMedtronic Vascular1997-07-14
K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.1997-07-10
K970497PACE 101HSulzer Oscor, Inc.1997-06-04
K960676ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004Zoll Medical Corp1996-06-05
K940467REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601Remington Medical, Inc.1994-11-01
K934016POWERCHARGERZoll Medical Corp1994-10-18
K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYERPace Medical1994-09-27
K923621EXTERNAL DEMAND PACEMAKEROscor Medical Corp.1993-05-19
K923398CPI MODEL 2215Seamed Corp.1992-08-14

Related GUDID Devices

Primary DIBrandCompanyPublished
00850056280020SoloPace EPGSOLO PACE INC.2026-02-02
00850056280013Solo Pace Control SystemSOLO PACE INC.2025-01-23
00850056280037Solo Pace Control SystemSOLO PACE INC.2025-01-23
04260451441173Osypka MedicalOsypka Medical GmbH2021-04-30
04260451441067CARDIOTRONIC Osypka Medical GmbH2021-04-30
04260451441050CARDIOTRONIC Osypka Medical GmbH2021-04-30
00763000162443NAMEDTRONIC, INC.2018-11-11
00643169723160NAMEDTRONIC, INC.2017-03-12
00643169725126NAMEDTRONIC, INC.2017-01-29
00847946021986HWD Electrode SetBIO-DETEK INCORPORATED2016-10-20
00885672005467PACE 203HOscor Inc.2016-09-17
04260451441012CARDIOTRONIC Osypka Medical GmbH2016-09-13
04260451441029CARDIOTRONIC Osypka Medical GmbH2016-09-13
00836559008859PACE 101HOscor Inc.2016-09-09
00836559008866PACE 203HOscor Inc.2016-09-09
006431693829785391Oscor Inc.2016-09-09
00847946021191PRO PADZBIO-DETEK INCORPORATED2016-08-03
00847946016661PRO PADZBIO-DETEK INCORPORATED2015-10-21
00643169508767NAMEDTRONIC, INC.2014-11-13
00847946016401PRO PADZBIO-DETEK INCORPORATED2014-09-24
00847946016463PRO PADZBIO-DETEK INCORPORATED2014-09-24
00643169230859NAMEDTRONIC, INC.2014-09-23
00643169305120NAMEDTRONIC, INC.2014-09-23
04035479010355PK-67-L/2,6mBIOTRONIK SE & Co. KG2014-08-20
04035479015473PK-67-S/0,8mBIOTRONIK SE & Co. KG2014-08-20
04035479049300PK-175/2,3mBIOTRONIK SE & Co. KG2014-08-19
04035479079581PK-83-B/2,5mBIOTRONIK SE & Co. KG2014-08-19
04035479080228PK-83-B/1,5mBIOTRONIK SE & Co. KG2014-08-19