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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 K904843
Device Name OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
Applicant
Dalton Instrument Corp.
P.O. Box 357
Sf-00101
Helsinki, Finland,  FI
Applicant Contact RAUNO RUOHO
Correspondent
Dalton Instrument Corp.
P.O. Box 357
Sf-00101
Helsinki, Finland,  FI
Correspondent Contact RAUNO RUOHO
Regulation Number868.1700
Classification Product Code
CBR  
Date Received10/25/1990
Decision Date 04/09/1991
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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