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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K053395
Device Name BP PRO BLOOD PRESSURE MONITOR
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Applicant Contact ALEX GONOROVSKY
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
P.O. Box 527
Rehovot,  IL 76100
Correspondent Contact ALEX GONOROVSKY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/06/2005
Decision Date 12/23/2005
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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