Product Code: MKJ


Products Classified as MKJ

877Automated External Defibrillators (non-wearable)Automated External Defibrillator System.

Total Product Life Cycle (TPLC) Devices

877Automated External Defibrillators (non-wearable)Automated External Defibrillator System.

FDA Consensus Standards

Automated External Defibrillators (Non-Wearable) [36797]21 CFR §870.5310 🔎

Pre-market Approvals for MKJ

P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery ChargerPhysio-Control. Inc.
P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-DEFIBTECH, LLC
P160034Powerheart® AED G3 ProCardiac Science Corporation
P160015CPR Stat-Padz Electrode and CPR-D Padz ElectrodeZOLL MEDICAL CORPORATION
P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and AccessoriesHeartSine Technologies LLC
P160033Powerheart G5 AEDCARDIAC SCIENCE CORPORATION
P160026LIFEPAK Automated External Defibrillators (AEDs)Physio-Control. Inc.
P170018LIFEPAK CR2 DefibrillatorPhysio-Control, Inc
P160022X Series/Propaq MDZOLL MEDICAL CORPORATION

Pre-market Notifications for MKJ

K150198CPR Dura-Padz Reusable Defibrillation Electrode With Dura-padz GelBio-Detek, Inc.
K150055OneStep Pediatric CPR Multi-Function ElectrodeBIO-DETEK, INC.
K143714Powerheart G5 AEDCARDIAC SCIENCE CORPORATION
K142915ZOLL X SeriesZOLL MEDICAL CORPORATION
K142803Skintact, Various Other TradenamesLeonhard Lang GmbH
K142709Samaritan PAD 450PHEARTSINE TECHNOLOGIES, INC.
K142430LIFEPAK 15 Monitor/defibrillatorPHYSIO-CONTROL, INC.
K141795BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500R & D BATTERIES, INC.
K141774ZOLL X SERIESZOLL MEDICAL CORPORATION
K141231ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERYZELLER POWER PRODUCTS (BATTERY BEAST, LLC)
K133659HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORINGPHILIPS MEDICAL SYSTEMS
K133484ZOLL X SERIESZOLL MEDICAL CORP.
K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODEBIO-DETEK, INC.
K133269ZOLL X SERIESZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
K133239ZOLL E SERIESZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

Global Unique Device Identification Database

10326053105736Automated External Defibrillators (Non-Wearable)
10304040016890Automated external defibrillators (non-wearable)
00681490974813Automated external defibrillators (non-wearable)
00681490587853Automated external defibrillators (non-wearable)
00681490583404Automated external defibrillators (non-wearable)
00681490583398Automated external defibrillators (non-wearable)
00681490583275Automated external defibrillators (non-wearable)
00681490581752Automated external defibrillators (non-wearable)
00681490580656Automated external defibrillators (non-wearable)
00681490577571Automated external defibrillators (non-wearable)
00681490577557Automated external defibrillators (non-wearable)
00681490577533Automated external defibrillators (non-wearable)
00681490577526Automated external defibrillators (non-wearable)
00681490577472Automated external defibrillators (non-wearable)
00681490577465Automated external defibrillators (non-wearable)

Maude Adverse Events

G3 PLUS AUTO, AED,GERMAN, PKGCARDIAC SCIENCE CORPORATION2020-03-31
X SERIESZOLL MEDICAL CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
X SERIESZOLL MEDICAL CORPORATION2020-03-31
AED PLUSZOLL MEDICAL CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
X SERIESZOLL MEDICAL CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
POWERHEART G5 KIT, AUTO, US EN/LA ESPCARDIAC SCIENCE CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
LIFEPAK? 12 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
E SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
POWERHEART G5 KIT, AUTO, DAN/INTL ENGCARDIAC SCIENCE CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
G3 PLUS AUTO, AED, AHA 2010, US ENGLISHCARDIAC SCIENCE CORPORATION2020-03-31
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-31
AED3ZOLL MEDICAL CORPORATION2020-03-31
LIFEPAK(R) 15 MONITOR/DEFIBRILLATORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK(R) 15 MONITOR/DEFIBRILLATORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK(R) 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK(R) 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK(R) 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK(R) 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-31
ZOLL X SERIES MONITOR DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-30
LIFEPAK(R) 15 MONITOR/DEFIBRILLATORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK(R) 20 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK(R) 20E DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 1000 DEFIBRILLATORPHYSIO-CONTROL, INC. - 30158762020-03-30
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
HEARTSTART ONSITEPHILIPS MEDICAL SYSTEMS2020-03-30
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-30
X SERIESZOLL MEDICAL CORPORATION2020-03-30
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-30
AED3ZOLL MEDICAL CORPORATION2020-03-30
AED PLUSZOLL MEDICAL CORPORATION2020-03-30
LIFEPAK? 15 DEFIBRILLATOR/MONITORPHYSIO-CONTROL, INC. - 30158762020-03-30
X SERIESZOLL MEDICAL CORPORATION2020-03-30
POWERHEART G5 KIT, SEMI, UKCARDIAC SCIENCE CORPORATION2020-03-30
R SERIES DEFIBRILLATORZOLL MEDICAL CORPORATION2020-03-30
X SERIESZOLL MEDICAL CORPORATION2020-03-30
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