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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 K142476
Device Name Master Caution Device MCD
Applicant
HealthWatch Ltd.
6 Hasadna Street
Kfar Saba,  IL 44424
Applicant Contact Yoram Levy
Correspondent
QSITE
31 HAAVODA STREET
BINYAMINA,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/03/2014
Decision Date 02/17/2015
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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