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 Philips Medical Systems, Physio-Control Corp. and Hewlett-Packard Co..

228
Total
228
Cleared
156d
Avg days
1985
Since
228 devices
25–48 of 228
Cleared Aug 05, 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871
Hewlett-Packard Co.
Cardiovascular · 65d
Cleared May 05, 1999
LIFEPAK 500 BIPHASIC
K983393
Physio-Control Corp.
Cardiovascular · 222d
Cleared Dec 17, 1998
HEARTSTREAM ELECTRODE ADAPTER
K984286
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Nov 05, 1998
MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K983287
Graphic Controls Corp.
Cardiovascular · 48d
Cleared Sep 04, 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR
K982025
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared May 12, 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
K980857
Graphic Controls Corp.
Cardiovascular · 68d
Cleared Jan 09, 1998
LIFE PAK 12
K973486
Physio-Control Corp.
Cardiovascular · 116d
Cleared Nov 06, 1997
LIFEPAK 300
K962359
Physio-Control Corp.
Cardiovascular · 505d
Cleared Aug 27, 1997
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Nov 04, 1996
LIFEPAK 500
K955854
Physio-Control Corp.
Cardiovascular · 312d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
K955882
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
K955923
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Jul 25, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS
K955828
Graphic Controls Corp.
Cardiovascular · 212d
Cleared May 07, 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957
Hewlett-Packard Co.
Cardiovascular · 193d
Cleared Jan 11, 1996
PEDIATRIC QUIK-COMBO
K953204
Physio-Control Corp.
Cardiovascular · 189d
Cleared Sep 07, 1995
MARQUETTE DEFIB ELECTRODES
K952101
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Apr 20, 1995
MARQUETTE DEFIB ELECTRODE
K941262
Marquette Electronics, Inc.
Cardiovascular · 400d
Cleared Dec 07, 1994
FAST-PATCH
K941970
Physio-Control Corp.
Cardiovascular · 229d
Cleared Jun 08, 1994
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR
K925936
Physio-Control Corp.
Cardiovascular · 579d
Cleared Feb 25, 1993
SERIES 1500 DEFIBRILLATOR, MODIFICATION
K926172
Marquette Electronics, Inc.
Cardiovascular · 86d
Cleared Jun 20, 1989
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
K892005
Physio-Control Corp.
Cardiovascular · 84d
Cleared Jun 05, 1989
LIFEPAK 250 DEFIBRILLATOR/MONITOR
K892065
Physio-Control Corp.
Cardiovascular · 67d
Cleared Nov 17, 1988
MARQUETTE 1200 DEFIBRILLATOR
K882067
Marquette Electronics, Inc.
Cardiovascular · 184d
Cleared Oct 11, 1985
LIFEPAK 200
K853564
Physio-Control Corp.
Cardiovascular · 46d