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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 K111693
Device Name PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
PHILIPS MEDICAL SYSTEMS
2301 5TH AVENUE, SUITE 200
SEATTLE,  WA  98121 -1825
Applicant Contact TAMARA YOUNT
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 5TH AVENUE, SUITE 200
SEATTLE,  WA  98121 -1825
Correspondent Contact TAMARA YOUNT
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/16/2011
Decision Date 10/28/2011
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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