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510(k) K912030

CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED by 3M Company — Product Code CBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
May 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1170
Review Panel
AN
Submission Type

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  • K912428 — PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (August 9, 1991)
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  • K803014 — SENSOMAT (December 22, 1980)