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
25–48 of 228
Cleared Dec 13, 2012
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K121853
Defibtech, LLC
Cardiovascular · 171d
Cleared Dec 13, 2012
ZOLL SUREPOWER SINGLE BAY CHARGER
K122839
ZOLL Medical Corporation
Cardiovascular · 87d
Cleared Nov 01, 2012
EXTENDED LIFE BATTERY
K120350
Aed Battery Exchange, LLC
Cardiovascular · 269d
Cleared Oct 26, 2012
ZOLL FULLY AUTOMATIC AED PLUS
K120406
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 260d
Cleared Oct 11, 2012
LIFEPAK 1000 DEFIBRILLATOR
K122600
Physio-Control, Inc.
Cardiovascular · 45d
Cleared Sep 25, 2012
ZOLL R SERIES
K120907
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 183d
Cleared Aug 06, 2012
HEART SYNC PEDIATRIC PHYSIO AED PAD
K120536
Heart Sync, Inc.
Cardiovascular · 166d
Cleared Apr 25, 2012
ZOLL PROPAQ MD
K112761
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 216d
Cleared Mar 21, 2012
ZOLL X SERIES
K112432
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 211d
Cleared Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
K110825
Philips Medical Systems
Cardiovascular · 330d
Cleared Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K111693
Philips Medical Systems
Cardiovascular · 134d
Cleared Aug 17, 2011
ZOLL E SERIES
K111594
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 71d
Cleared May 13, 2011
ONESTEP PEDIATRIC MFE'S
K110978
ZOLL Medical Corporation
Cardiovascular · 36d
Cleared Apr 13, 2011
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
K110742
ZOLL Medical Corporation
Cardiovascular · 27d
Cleared Mar 25, 2011
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110526
ZOLL Medical Corporation
Cardiovascular · 29d
Cleared Mar 22, 2011
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K103567
Physio-Control, Inc.
Cardiovascular · 106d
Cleared Mar 08, 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110361
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 29d
Cleared Feb 17, 2011
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110154
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 29d
Cleared Feb 17, 2011
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
K110168
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 28d
Cleared Feb 08, 2011
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
K103186
Leonhard Lang GmbH
Cardiovascular · 102d
Cleared Nov 16, 2010
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
K100565
Bio-Detek, Inc.
Cardiovascular · 260d
Cleared Sep 23, 2010
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
K091561
ZOLL Medical Corporation
Cardiovascular · 483d
Cleared Dec 23, 2009
ZOLL E SERIES WITH CPRREADYCHARGE
K091265
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 237d
Cleared Dec 03, 2009
ZOLL E SERIES WITH SPCO/SPMET OPTION
K092598
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 101d