PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K022929
Device Name PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210
Original Applicant
CARDIAC SCIENCE, INC.
16931 millikan ave.
irvine, 
CA 
92606

Original Contact john carline
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 09/04/2002
Decision Date 01/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No