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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 K013425
Device Name HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
Applicant
Philips Medical Systems
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact TAMARA YOUNT
Correspondent
Philips Medical Systems
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact TAMARA YOUNT
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received10/16/2001
Decision Date 01/14/2002
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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