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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 K143359
Device Name CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
Applicant
LifeWatch Technologies Ltd.
2 Pekeris St.
rehovot,  IL 7670202
Applicant Contact asher kassel
Correspondent
Life Watch
10255 W Higgins Road, Suite 100
chicago,  IL  60018
Correspondent Contact stephen slavens
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received11/24/2014
Decision Date 09/11/2015
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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