Cleared Traditional

OPTEX BLOOD GAS MONITORING SYSTEM

K896311 · Optex Biomedical · Anesthesiology

Jan 1990

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K896311 is an FDA 510(k) clearance for the OPTEX BLOOD GAS MONITORING SYSTEM, a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II — Special Controls, product code CCE), submitted by Optex Biomedical (The Woodlands, US). The FDA issued a Cleared decision on January 3, 1990, 63 days after receiving the submission on November 1, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1200.

Submission Details

510(k) Number	K896311 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1989
Decision Date	January 03, 1990
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.1200