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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
Other 510(k) Applications for this Contact
Regulation Number
870.2850
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Classification Product Code
DRS
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More FDA Info for this Product Code
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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