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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 K872760
Device Name OSCAR(TM) PB255 OXIMETER CAPNOMETER
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 Number868.1400
Classification Product Code
CCK  
Date Received07/13/1987
Decision Date 09/14/1987
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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