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510(k) K860106

OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 by American Bentley — Product Code CCE

K860106 is an FDA 510(k) premarket notification submitted by American Bentley for the device "OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100". The FDA issued a decision of Substantially Equivalent on February 26, 1986. 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. American Bentley has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
January 13, 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 American Bentley

  • K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (February 12, 1988)
  • K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (November 6, 1987)
  • K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (September 1, 1987)
  • K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (September 1, 1987)
  • K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS (August 24, 1987)
  • K870911 — INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (May 29, 1987)
  • K870269 — ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 (March 9, 1987)
  • K863249 — OXYGENATOR MODEL NO. BENTLEY-10 PLUS (October 20, 1986)
  • K861641 — HEPARIN-COATED EXTRACORPOREAL CIRCUITS (September 29, 1986)
  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)

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)
  • 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)

FDA data resources