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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 K101703
Device Name MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
555 ZANG STREET
SUITE 100
lakewood,  CO  80228
Applicant Contact clay aneselmo
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
555 ZANG STREET
SUITE 100
lakewood,  CO  80228
Correspondent Contact clay aneselmo
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received06/17/2010
Decision Date 07/13/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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