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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 K120536
Device Name HEART SYNC PEDIATRIC PHYSIO AED PAD
Original Applicant
HEART SYNC INC.
8870 ravello ct
naples,  FL  34114
Original Contact daniel kamm
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/22/2012
Decision Date 08/06/2012
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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