FDA 510(k) Application Details - K120624

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K120624
Device Name Transducer, Blood-Pressure, Extravascular
Applicant ELCAM MEDICAL A.C.A.L
M.P. MEROM HA'GALIL
KIBBUTZ BARAM 13860 IL
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Contact AHARON COHEN
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 03/01/2012
Decision Date 06/08/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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