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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K113514
Device Name SMARTHEART
Original Applicant
SHL TELEMEDICINE INTERNATIONAL LTD.
31 haavoda st.
binyamina,  IL 30500
Original Contact yoram levy
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/28/2011
Decision Date 02/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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