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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 K013879
Device Name TM2000, MODEL 1
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 Received11/23/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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