HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K021453
Device Name HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
Original Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810

Original Contact richard j petersen
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LDD  
Date Received 05/06/2002
Decision Date 07/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls