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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 K071995
Device Name CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St. P.O. Box 527
Rehovot,  IL 76101
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St. P.O. Box 527
Rehovot,  IL 76101
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received07/20/2007
Decision Date 12/18/2007
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
Recalls CDRH Recalls
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