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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling
510(k) Number K912030
Device Name CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
Applicant
3M COMPANY
1311 VALENCIA AVE.
TUSTIN,  CA  92680
Applicant Contact STEVEN ARICK
Correspondent
3M COMPANY
1311 VALENCIA AVE.
TUSTIN,  CA  92680
Correspondent Contact STEVEN ARICK
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received05/07/1991
Decision Date 10/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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