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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K060911
Device Name CG-6108 ARRHYTHMIA ECG EVENT RECORDER
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
rehovot,  IL 76100
Applicant Contact alex gonorovsky
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
rehovot,  IL 76100
Correspondent Contact alex gonorovsky
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/03/2006
Decision Date 08/22/2006
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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