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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 K890112
Device Name ENGSTROM ELIZA + CO2 ANALYZER
Applicant
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Applicant Contact JEFFREY SHIDEMAN,PHD
Correspondent
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Correspondent Contact JEFFREY SHIDEMAN,PHD
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/11/1989
Decision Date 03/15/1989
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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