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510(k) K875225

UMBILICAL ARTERY OXYGEN SENSOR by Ohmeda Medical — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
December 22, 1987
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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