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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 K040404
Device Name HEARTSTART MRX, MODEL M3535A
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD. MS 0222
ANDOVER,  MA  01810 -1099
Applicant Contact PETER OHANIAN
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD. MS 0222
ANDOVER,  MA  01810 -1099
Correspondent Contact PETER OHANIAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/17/2004
Decision Date 05/04/2004
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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