OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100— 510(k) K853786

Name: FDA 510(k) clearance K853786
Creator: U.S. Food and Drug Administration
Published: 1985-10-16

Substantially Equivalent

American Bentley

FDA 510(k) clearance K853786 for OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100, Substantially Equivalent on 1985-10-16. Applicant: American Bentley. Device class: 2.

Clearance details

Applicant: American Bentley
Product code: Code CCE
Device class: Class 2
Regulation: 21 CFR 868.1200
Advisory panel: Anesthesiology
Date received: 1985-09-10
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCE

view all

K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM1996-12-05
K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA1992-05-05
K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE1991-08-13
K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM1991-05-14
K896311 — OPTEX BLOOD GAS MONITORING SYSTEM1990-01-03

More clearances from American Bentley

view all

K872896 — UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-1001988-02-12
K873923 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER1987-11-06
K870804 — CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-1001987-09-01
K872167 — CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-35001987-09-01
K872133 — OXYGENATOR MODEL NO. BENTLEY 5 PLUS1987-08-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.