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510(k) K896311

OPTEX BLOOD GAS MONITORING SYSTEM by Optex Biomedical — Product Code CCE

K896311 is an FDA 510(k) premarket notification submitted by Optex Biomedical for the device "OPTEX BLOOD GAS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 1990. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1990
Date Received
November 1, 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

Other clearances for product code CCE

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  • K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (May 5, 1992)
  • K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE (August 13, 1991)
  • K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (May 14, 1991)
  • K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II (December 22, 1989)
  • K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (November 28, 1989)
  • K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (November 28, 1989)
  • K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (December 16, 1988)
  • K875225 — UMBILICAL ARTERY OXYGEN SENSOR (March 4, 1988)
  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)

FDA data resources