Home / 510(k) Clearances / K860808

510(k) K860808

CONTINUCATH by Orange Medical Instruments, Inc. — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1986
Date Received
March 4, 1986
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 Orange Medical Instruments, Inc.

  • K851822 — BETA SCAN TRENDS METER (October 3, 1985)
  • K844796 — MICRO-BETA U100 SYRINGE (December 18, 1984)
  • K843882 — TRENDS LANCET (November 5, 1984)
  • K841369 — BETA SCAN DRYSTIX (August 23, 1984)
  • K833705 — BETAJECT BD U100 (May 9, 1984)
  • K833706 — CLICK-COUNT U100 INSULIN SYRINGE (April 5, 1984)
  • K832691 — BETA SCAN REAGENT STRIP (November 14, 1983)
  • K832793 — NEOCATH 1000 W/HEPCOTE (September 26, 1983)
  • K831897 — BETA I PROGRAMMABLE INFUSION PUMP (August 12, 1983)
  • K831523 — BETA SCAN NORMAL CONTROL SOLUTION (July 19, 1983)

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)