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
Cleared
Oct 07, 1993
D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT
Zoll Medical Corp
Cardiovascular
113d
Cleared
Feb 25, 1993
SERIES 1500 DEFIBRILLATOR, MODIFICATION
Marquette Electronics, Inc.
Cardiovascular
86d
Cleared
Jun 20, 1989
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
Physio-Control Corp.
Cardiovascular
84d
Cleared
Jun 05, 1989
LIFEPAK 250 DEFIBRILLATOR/MONITOR
Physio-Control Corp.
Cardiovascular
67d
Cleared
Nov 17, 1988
MARQUETTE 1200 DEFIBRILLATOR
Marquette Electronics, Inc.
Cardiovascular
184d
Cleared
Apr 10, 1987
HEART*AID 1000
Cardiac Resucitator Corp.
Cardiovascular
57d
Cleared
Oct 11, 1985
LIFEPAK 200
Physio-Control Corp.
Cardiovascular
46d