FDA 510(k) Application Details - K954962

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

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510(K) Number K954962
Device Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Applicant SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND, WA 98073-9713 US
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Contact RUSS GARRISON
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Regulation Number 868.1700

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Classification Product Code CBR
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Date Received 10/30/1995
Decision Date 05/31/1996
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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