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
FDA 510(k) Cleared Automated External Defibrillators (non-wearable) Devices (Product Code MKJ)
228 devices
Cleared
May 04, 2015
Powerheart G5 AED
Cardiac Science Corporation
Cardiovascular
126d
Cleared
May 02, 2015
OneStep Pediatric CPR Multi-Function Electrode
Bio-Detek, Inc.
Cardiovascular
110d
Cleared
May 02, 2015
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
Bio-Detek, Inc.
Cardiovascular
93d
Cleared
Mar 27, 2015
samaritan PAD 450P
Heartsine Technologies, Inc.
Cardiovascular
186d
Cleared
Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
Philips Medical Systems
Cardiovascular
422d
Cleared
Jan 16, 2015
ZOLL E SERIES
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
452d
Cleared
Dec 19, 2014
LIFEPAK 15 monitor/defibrillator
Physio-Control, Inc.
Cardiovascular
112d
Cleared
Dec 08, 2014
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
R & D Batteries, Inc.
Cardiovascular
158d
Cleared
Dec 03, 2014
ZOLL X Series
ZOLL Medical Corporation
Cardiovascular
57d
Cleared
Dec 02, 2014
Skintact, various other tradenames
Leonhard Lang GmbH
Cardiovascular
64d
Cleared
Nov 25, 2014
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
Zeller Power Products (Battery Beast, LLC)
Cardiovascular
196d
Cleared
Nov 19, 2014
ZOLL X SERIES
ZOLL Medical Corporation
Cardiovascular
140d
Cleared
Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
Bio-Detek, Inc.
Cardiovascular
332d
Cleared
Aug 01, 2014
ZOLL X SERIES
Zoll Medical Corp
Cardiovascular
261d
Cleared
May 22, 2014
ZOLL X SERIES
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular
210d
Cleared
Apr 24, 2014
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Defibtech, LLC
Cardiovascular
331d
Cleared
Feb 12, 2014
POWERHEART G5 AED
Cardiac Science Corporation
Cardiovascular
520d
Cleared
Dec 06, 2013
HEART SYNC
Heart Sync, Inc.
Cardiovascular
191d
Cleared
Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
Philips Medical Systems
Cardiovascular
219d
Cleared
Sep 16, 2013
HEART SYNC
Heart Sync, Inc.
Cardiovascular
116d
Cleared
Aug 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
Physio-Control, Inc.
Cardiovascular
180d
Cleared
Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
Heartsine Technologies, Inc.
Cardiovascular
206d
Cleared
Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
Philips Medical Systems
Cardiovascular
49d
Cleared
Jan 04, 2013
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Defibtech, LLC
Cardiovascular
379d