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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 K050004
Device Name PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
Applicant
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Applicant Contact TISHA TREHERNE
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 FIFTH AVE., SUITE 200
SEATTLE,  WA  98121
Correspondent Contact TISHA TREHERNE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received01/02/2005
Decision Date 02/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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