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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 K083174
Device Name HEALTHEPOD
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St., Science Park
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
FLL  
Date Received10/27/2008
Decision Date 12/17/2009
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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