MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K022210
Device Name MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
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 07/08/2002
Decision Date 10/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No