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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, Oxygen, Gaseous-Phase
510(k) Number K896427
Device Name SPACELABS' MODEL 90514, MULTIGAS ANALYZER
Applicant
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Applicant Contact W GIFFORD
Correspondent
Spacelabs, Inc.
15220 NE 40th St.
P.O. Box 97013
Redmond,  WA  98073
Correspondent Contact W GIFFORD
Regulation Number868.1720
Classification Product Code
CCL  
Date Received11/08/1989
Decision Date 01/24/1990
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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