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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 K000225
Device Name CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
P.O.B. 527
Rehovot,  IL 76100
Applicant Contact LEONID TRACHTENBERG
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
P.O.B. 527
Rehovot,  IL 76100
Correspondent Contact LEONID TRACHTENBERG
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/24/2000
Decision Date 02/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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