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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
510(k) Number K954962
Device Name SPACELABS MEDICAL MULTIGAS ANALYZER
Applicant
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Applicant Contact RUSS GARRISON
Correspondent
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Correspondent Contact RUSS GARRISON
Regulation Number868.1700
Classification Product Code
CBR  
Date Received10/30/1995
Decision Date 05/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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