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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 K905754
Device Name CAPNOMAC ULTIMA ANESTHESIA MONITOR
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Applicant Contact HANNU AHJOPALO
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Correspondent Contact HANNU AHJOPALO
Regulation Number868.1620
Classification Product Code
CBS  
Date Received12/24/1990
Decision Date 06/17/1991
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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