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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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