FDA 510(k) Application Details - K961404

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K961404
Device Name Transducer, Blood-Pressure, Extravascular
Applicant MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact JOHN C TOOMEY
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 04/11/1996
Decision Date 06/27/1996
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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