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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 K130153
Device Name HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Applicant Contact MARK PUOPOLO
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Correspondent Contact MARK PUOPOLO
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DPS   DQA   DRO   DXN  
LDD   LIX   MWI  
Date Received01/22/2013
Decision Date 03/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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