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510(k) K853786

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 by American Bentley — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
September 10, 1985
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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