Cleared Traditional

MARK III OXYGEN WALKER SYSTEM

K820836 · Union Carbide Corp. · Anesthesiology
Apr 1982
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K820836 is an FDA 510(k) clearance for the MARK III OXYGEN WALKER SYSTEM, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1982, 20 days after receiving the submission on March 26, 1982. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K820836 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1982
Decision Date April 15, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYJ — Unit, Liquid-oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5655

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