Cleared Traditional

LINDE MARK II

K812536 · Union Carbide Corp. · Anesthesiology
Sep 1981
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K812536 is an FDA 510(k) clearance for the LINDE MARK II, 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 September 23, 1981, 20 days after receiving the submission on September 3, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K812536 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1981
Decision Date September 23, 1981
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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