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
49–72 of 228
Cleared Sep 23, 2009
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
K090989
Zoll Medical Corp
Cardiovascular · 169d
Cleared Mar 09, 2009
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
K081081
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 327d
Cleared Dec 09, 2008
ZOLL R SERIES BLS DEFIBRILLATOR
K081828
ZOLL Medical Corporation
Cardiovascular · 165d
Cleared Dec 04, 2008
ZOLL E SERIES WITH INTIBATION ASSIST OPTION
K080903
ZOLL Medical Corporation
Cardiovascular · 247d
Cleared Sep 24, 2008
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
K081371
Leonhard Lang GmbH
Cardiovascular · 132d
Cleared Apr 24, 2008
ZOLL E SERIES DEFIBRILLATOR
K072923
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 192d
Cleared Apr 23, 2008
ZOLL E SERIES 12SL, ANALYSIS OPTION
K080232
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 84d
Cleared Feb 26, 2008
PHILIPS HEARTSTART SMARTPADS III
K072812
Philips Medical Systems
Cardiovascular · 148d
Cleared Nov 06, 2007
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE
K072430
ZOLL Medical Corporation
Cardiovascular · 69d
Cleared Oct 05, 2007
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
K072233
Leonhard Lang GmbH
Cardiovascular · 56d
Cleared Jun 22, 2007
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
K071025
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 72d
Cleared Apr 26, 2007
ZOLL E SERIES WITH SEE-THRU CPR
K070455
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 69d
Cleared Feb 28, 2007
ZOLL M SERIES WITH REAL CPR HELP
K062537
ZOLL Medical Corporation
Cardiovascular · 183d
Cleared Jan 11, 2007
HEARTSTART MRX, MODELS M3535A OR M3536A
K063375
Philips Medical Systems
Cardiovascular · 64d
Cleared Dec 13, 2006
ZOLL E SERIES WITH REAL CPR HELP
K062177
ZOLL Medical Corporation
Cardiovascular · 135d
Cleared Dec 12, 2006
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
K052465
Heartsine Technologies, Inc.
Cardiovascular · 460d
Cleared Nov 22, 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233
Philips Medical Systems North America, Inc.
Cardiovascular · 112d
Cleared Aug 17, 2006
ZOLL R SERIES DEFIBRILLATOR
K060559
ZOLL Medical Corporation
Cardiovascular · 168d
Cleared Aug 11, 2006
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
K061707
Philips Medical Systems
Cardiovascular · 56d
Cleared Feb 17, 2006
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K052057
Medtronic Emergency Response Systems, Inc.
Cardiovascular · 203d
Cleared Jan 03, 2006
POWERHEART ECD
K052316
Cardiac Science, Inc.
Cardiovascular · 131d
Cleared Dec 22, 2005
LIFEPAK, MODEL 1000
K042404
Medtronic Emergency Response Systems, Inc.
Cardiovascular · 475d
Cleared Oct 21, 2005
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
K052161
Cardiac Science, Inc.
Cardiovascular · 73d
Cleared Oct 05, 2005
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
K051632
Philips Medical Systems
Cardiovascular · 107d