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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-Monoxide, Gaseous-Phase
510(k) Number K833739
Device Name CD-102 CARBON DIOXIDE ANALYZER/RECOR
Applicant
Instrumentarium Corp.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent
Instrumentarium Corp.
2 Highwood Dr.
Tewksbury,  MA  01876
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received10/25/1983
Decision Date 12/16/1983
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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