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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 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Applicant Contact RUSS GARRISON
Correspondent
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
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
Predetermined Change
Control Plan Authorized		 No
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