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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
Applicant
Heart Sync, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Heart Sync, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/22/2012
Decision Date 08/06/2012
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
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