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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, Halothane, Gaseous-Phase (Anesthetic Conc.)
510(k) Number K832113
Device Name NORMAC ANESTHETIC AGENT MONITOR
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 357
Sf-00101
Helsinki 10 Finland, 
Regulation Number868.1620
Classification Product Code
CBS  
Date Received06/30/1983
Decision Date 09/12/1983
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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