OPTEX BLOOD GAS MONITORING SYSTEM— 510(k) K896311

Name: FDA 510(k) clearance K896311
Creator: U.S. Food and Drug Administration
Published: 1990-01-03

Substantially Equivalent

Optex Biomedical

FDA 510(k) clearance K896311 for OPTEX BLOOD GAS MONITORING SYSTEM, Substantially Equivalent on 1990-01-03. Applicant: Optex Biomedical. Device class: 2.

Clearance details

Applicant: Optex Biomedical
Product code: Code CCE
Device class: Class 2
Regulation: 21 CFR 868.1200
Advisory panel: Anesthesiology
Date received: 1989-11-01
Decision date: 1990-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Woodlands, TX, US

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