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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 K891076
Device Name CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
Applicant
Datex Division Instrumentarium Corp.
127 Upham St.
Melrose,  MA  02176
Applicant Contact JOUKO VALLIKARI
Correspondent
Datex Division Instrumentarium Corp.
127 Upham St.
Melrose,  MA  02176
Correspondent Contact JOUKO VALLIKARI
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/28/1989
Decision Date 08/02/1989
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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