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
121–144 of 228
Cleared Aug 23, 1999
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
K991007
Katecho, Inc.
Cardiovascular · 150d
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 Mar 16, 1999
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
K984582
Bio-Detek, Inc.
Cardiovascular · 83d
Cleared Mar 11, 1999
ZOLL M SERIES SPO2 OPTION
K982992
Zoll Medical Corp
Cardiovascular · 196d
Cleared Feb 26, 1999
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
K990106
Bio-Detek, Inc.
Cardiovascular · 45d
Cleared Jan 25, 1999
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
K982264
Survivalink Corp.
Cardiovascular · 210d
Cleared Dec 17, 1998
HEARTSTREAM ELECTRODE ADAPTER
K984286
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Dec 09, 1998
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
K981737
Katecho, Inc.
Cardiovascular · 205d
Cleared Nov 25, 1998
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
K981802
Bio-Detek, Inc.
Cardiovascular · 188d
Cleared Nov 20, 1998
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
K983307
Medical Research Laboratories, Inc.
Cardiovascular · 60d
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 Aug 10, 1998
AECD ARRHYTHMIA DETECTION SOFTWARE
K982710
Cardiac Science, Inc.
Cardiovascular · 6d
Cleared Jun 26, 1998
LIFE SUPPORT FOR TRAUMA AND TRANSPORT
K965117
Northrop Grumman Corp.
Cardiovascular · 553d
Cleared May 12, 1998
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
K980857
Graphic Controls Corp.
Cardiovascular · 68d
Cleared Mar 16, 1998
ZOLL REVIVER
K972241
Zoll Medical Corp
Cardiovascular · 273d
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 Oct 16, 1997
POWERHEART AECD
K970741
Cardiac Science, Inc.
Cardiovascular · 230d
Cleared Sep 25, 1997
HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)
K972418
Heartstream, Inc.
Cardiovascular · 90d
Cleared Aug 27, 1997
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Jul 28, 1997
FIRST MEDIC PULSE OXIMETRY MODULE
K955890
Colorado Medtech, Inc.
Cardiovascular · 577d
Cleared Jun 23, 1997
SVL-9130 DEFIBRILLATION ELECTRODE
K971149
Survivalink Corp.
Cardiovascular · 87d