Cleared Traditional

VENOUS OXYGEN PROBE

K811071 · G.D. Searle and Co. · Anesthesiology

May 1981

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K811071 is an FDA 510(k) clearance for the VENOUS OXYGEN PROBE, a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II — Special Controls, product code CCE), submitted by G.D. Searle and Co. (Walker, US). The FDA issued a Cleared decision on May 5, 1981, 15 days after receiving the submission on April 20, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1200.

Submission Details

510(k) Number	K811071 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 1981
Decision Date	May 05, 1981
Days to Decision	15 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