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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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