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FDA 510(k) Application Details - K974903
Device Classification Name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
More FDA Info for this Device
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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More FDA Info for this Product Code
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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