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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 K110499
Device Name CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Applicant
CARD GUARD SCIENTIFIC SURVIVAL LTD.
555 ZANG ST
SUITE 100
LAKEWOOD,  CO  80228
Applicant Contact CLAY ANSELMO
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL LTD.
555 ZANG ST
SUITE 100
LAKEWOOD,  CO  80228
Correspondent Contact CLAY ANSELMO
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received02/22/2011
Decision Date 04/06/2011
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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