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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 K051632
Device Name PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
Applicant
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Applicant Contact TAMARA YOUNT
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Correspondent Contact TAMARA YOUNT
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/20/2005
Decision Date 10/05/2005
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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