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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
Contact teresa skarr
Regulation Number870.5310
Classification Product Code
NSA  
Date Received04/09/2004
Decision Date 09/16/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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