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510(k) K811071

VENOUS OXYGEN PROBE by G.D. Searle and Co. — Product Code CCE

K811071 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "VENOUS OXYGEN PROBE". The FDA issued a decision of Substantially Equivalent on May 5, 1981. 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. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
April 20, 1981
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 by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)
  • K802280 — WHITE KNIGHT DRAPE SEAL (October 10, 1980)

Other clearances for product code CCE

  • K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (December 5, 1996)
  • 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)
  • K896311 — OPTEX BLOOD GAS MONITORING SYSTEM (January 3, 1990)
  • K890624 — TISSUE OXYGEN MONITOR SYSTEM, MODEL II (December 22, 1989)
  • K895149 — NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (November 28, 1989)
  • K895150 — CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (November 28, 1989)
  • K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (December 16, 1988)
  • K875225 — UMBILICAL ARTERY OXYGEN SENSOR (March 4, 1988)

FDA data resources