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510(k) K890624

TISSUE OXYGEN MONITOR SYSTEM, MODEL II by Baxter Healthcare Corp — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
February 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type

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