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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name over-the-counter automated external defibrillator
510(k) Number K040904
Device Name PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
Applicant
PHILIPS MEDICAL SYSTEMS
2301 5TH AVENUE, SUITE 200
SEATTLE,  WA  98121 -1825
Applicant Contact TERESA SKARR
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 5TH AVENUE, SUITE 200
SEATTLE,  WA  98121 -1825
Correspondent Contact TERESA SKARR
Regulation Number870.5310
Classification Product Code
NSA  
Date Received04/07/2004
Decision Date 09/16/2004
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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