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 Philips Medical Systems.

228
Total
228
Cleared
156d
Avg days
1985
Since
228 devices
97–120 of 228
Cleared Mar 25, 2002
ZOLL PAD
K011388
Zoll Medical Corp
Cardiovascular · 322d
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766
Medical Research Laboratories, Inc.
Cardiovascular · 159d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157
Philips Medical Systems
Cardiovascular · 29d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425
Philips Medical Systems
Cardiovascular · 90d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030
Medical Research Laboratories, Inc.
Cardiovascular · 88d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 11, 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
K010634
Agilent Technologies, Inc.
Cardiovascular · 101d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819
Agilent Technologies, Inc.
Cardiovascular · 142d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257
Zoll Medical Corp
Cardiovascular · 30d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280
Medical Devices, Inc.
Cardiovascular · 194d
Cleared Dec 20, 2000
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 14, 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228
Katecho, Inc.
Cardiovascular · 59d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232
Medical Research Laboratories, Inc.
Cardiovascular · 135d
Cleared Nov 21, 2000
K-DEFIB/PACE, MODEL KDP-60A
K002806
Katecho, Inc.
Cardiovascular · 74d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725
Agilent Technologies, Inc.
Cardiovascular · 94d
Cleared May 18, 2000
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
K992543
Hewlett-Packard Co.
Cardiovascular · 293d
Cleared Feb 28, 2000
ZOLL M SERIES ETCO2 OPTION
K993036
Zoll Medical Corp
Cardiovascular · 172d
Cleared Feb 03, 2000
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
K993745
Katecho, Inc.
Cardiovascular · 90d
Cleared Jan 24, 2000
POWERHEART AECD
K993533
Cardiac Science, Inc.
Cardiovascular · 97d
Cleared Dec 10, 1999
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
K993072
Survivalink Corp.
Cardiovascular · 87d
Cleared Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Oct 21, 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556
Zoll Medical Corp
Cardiovascular · 170d
Cleared Sep 03, 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762
Zoll Medical Corp
Cardiovascular · 179d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910
Physio-Control Corp.
Cardiovascular · 88d