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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K151835
Device Name Vital Signs Patch System
Applicant
Lifewatch Technologies , Ltd.
2 Pekeris St.
Rehovot,  IL 7670202
Applicant Contact ASHER KASSEL
Correspondent
Lifewatch Technologies , Ltd.
2 Pekeris St.
Rehovot,  IL 7670202
Correspondent Contact ASHER KASSEL
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DQA   MHX  
Date Received07/06/2015
Decision Date 02/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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