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 Hewlett-Packard Co..
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 18, 2000
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
Hewlett-Packard Co.
Cardiovascular
293d
Cleared
Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
Hewlett-Packard Co.
Cardiovascular
89d
Cleared
Aug 05, 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
Hewlett-Packard Co.
Cardiovascular
65d
Cleared
Dec 17, 1998
HEARTSTREAM ELECTRODE ADAPTER
Hewlett-Packard Co.
Cardiovascular
16d
Cleared
Sep 04, 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR
Hewlett-Packard Co.
Cardiovascular
87d
Cleared
May 07, 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
Hewlett-Packard Co.
Cardiovascular
193d