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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 K151269
Device Name ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
Applicant
Lifewatch Technologies , Ltd.
2 Pekeris St.
Rehovot,  IL 0202
Applicant Contact Asher Kassel
Correspondent
Biologics Consulting Group, Inc.
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received05/13/2015
Decision Date 01/15/2016
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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