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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 K884228
Device Name CDI(R) 2000 BLOOD GAS MONITOR
Applicant
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Applicant Contact STEVEN ARICK
Correspondent
Cardiovascular Devices, Inc.
2801 Barranca
Irvine,  CA  92714
Correspondent Contact STEVEN ARICK
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received10/07/1988
Decision Date 01/30/1989
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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