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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K941165
Device Name COMET CAPNOGRAPH MODULE
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 Number868.1400
Classification Product Code
CCK  
Date Received03/11/1994
Decision Date 10/06/1994
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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