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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 K081257
Device Name CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/02/2008
Decision Date 05/29/2008
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
Recalls CDRH Recalls
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