MKJ · Class III · 21 CFR 870.5310

FDA Product Code MKJ: Automated External Defibrillators (non-wearable)

This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.

Leading manufacturers include Zoll Medical Corp, Zoll Medical Corporation, World Wide Headquarters and ZOLL Medical Corporation.

228
Total
228
Cleared
156d
Avg days
1985
Since
228 devices
73–96 of 228
Cleared Sep 08, 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134
Philips Medical Systems
Cardiovascular · 128d
Cleared Jun 24, 2005
ZOLL M SERIES 12SL ANALYSIS OPTION
K051475
ZOLL Medical Corporation
Cardiovascular · 21d
Cleared May 13, 2005
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
K051076
ZOLL Medical Corporation
Cardiovascular · 16d
Cleared Apr 07, 2005
ZOLL E SERIES DEFIBRILLATOR
K042007
Zoll Medical Corp
Cardiovascular · 255d
Cleared Feb 25, 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004
Philips Medical Systems
Cardiovascular · 54d
Cleared Feb 04, 2005
ZOLL AED PRO EXTERNAL DEFIBRILLATOR
K041892
ZOLL Medical Corporation
Cardiovascular · 206d
Cleared Oct 05, 2004
ZOLL M SERIES ETC02 LOFLO OPTION
K042417
Zoll Medical Corp
Cardiovascular · 28d
Cleared Sep 14, 2004
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479
Welch Allyn, Inc.
Cardiovascular · 202d
Cleared Sep 07, 2004
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21
K041883
Leonhard Lang GmbH
Cardiovascular · 57d
Cleared Sep 02, 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
K042088
Heartsine Technologies, Inc.
Cardiovascular · 30d
Cleared Jul 01, 2004
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K041459
Medtronic Emergency Response Systems, Inc.
Cardiovascular · 29d
Cleared May 25, 2004
HEARTSINE SAMARITAN PAD
K041067
Heartsine Technologies, Inc.
Cardiovascular · 32d
Cleared May 21, 2004
ZOLL AED PLUS
K033474
Zoll Medical Corp
Cardiovascular · 200d
Cleared May 04, 2004
HEARTSTART MRX, MODEL M3535A
K040404
Philips Medical Systems, Inc.
Cardiovascular · 77d
Cleared Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
K040056
Bio-Detek, Inc.
Cardiovascular · 87d
Cleared Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
K040256
Bio-Detek, Inc.
Cardiovascular · 65d
Cleared Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K032421
Ambu, Inc.
Cardiovascular · 206d
Cleared Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
K033771
Bio-Detek, Inc.
Cardiovascular · 86d
Cleared Nov 05, 2003
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K032439
Zoll Medical Corp
Cardiovascular · 90d
Cleared Aug 27, 2003
HEARTSTART MRX, MODEL M3535A
K031187
Philips Medical Systems
Cardiovascular · 134d
Cleared Nov 08, 2002
PHILIPS M5066A AND M5068A
K020715
Philips Medical Systems
Cardiovascular · 248d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453
Philips Medical Systems
Cardiovascular · 58d
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168
Medical Research Laboratories, Inc.
Cardiovascular · 76d
Cleared Apr 11, 2002
ZOLL PAD WITH CPR AID
K011541
Zoll Medical Corp
Cardiovascular · 328d