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510(k) K915073

MARQUETTE SV O2 MODULE by Marquette Electronics, Inc. — Product Code DQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1992
Date Received
November 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Oximeter, Fiber-Optic
Device Class
Class II
Regulation Number
870.1230
Review Panel
CV
Submission Type

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  • K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (November 3, 2006)
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  • K061159 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (June 26, 2006)
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