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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K120624
Device Name ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
Original Applicant
ELEAM MEDICAL A.C.A.L
m.p. merom ha'galil
kibbutz baram,  IL 13860
Original Contact aharon cohen
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/01/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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