FDA 510(k) Application Details - K974903

Device Classification Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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510(K) Number K974903
Device Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Applicant DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS, NJ 07653 US
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Contact RUSSELL OLSEN
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Regulation Number 868.1620

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Classification Product Code CBS
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Date Received 12/31/1997
Decision Date 03/13/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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