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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 K013175
Device Name TM2000 EASYTRACE PLUS RECEIVING CENTER
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 Received09/24/2001
Decision Date 10/30/2001
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
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