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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 K042254
Device Name PMP4 SELFCHECK ECG
Applicant
Card Guard Scientific Survival , Ltd.
2 Pereris St., Science Park
Rehovot,  IL 76100
Applicant Contact NAAMA OREN
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pereris St., Science Park
Rehovot,  IL 76100
Correspondent Contact NAAMA OREN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/20/2004
Decision Date 01/13/2005
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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