OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100— 510(k) K860106

Name: FDA 510(k) clearance K860106
Creator: U.S. Food and Drug Administration
Published: 1986-02-26

Substantially Equivalent

American Bentley

FDA 510(k) clearance K860106 for OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100, Substantially Equivalent on 1986-02-26. 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: 1986-01-13
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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