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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K021453
Device Name HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact RICHARD J PETERSEN
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact RICHARD J PETERSEN
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LDD  
Date Received05/06/2002
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
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