Cleared Traditional

LINDE MARK II OXYGEN RESERV. TYPE OR-4

K810732 · Union Carbide Corp. · Anesthesiology
Mar 1981
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K810732 is an FDA 510(k) clearance for the LINDE MARK II OXYGEN RESERV. TYPE OR-4, 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 March 27, 1981, 10 days after receiving the submission on March 17, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K810732 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1981
Decision Date March 27, 1981
Days to Decision 10 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

Similar Devices — BYJ Unit, Liquid-oxygen, Portable

All 54
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
K130068 · Essex Industries, Inc. D/B/A Essex Cryogenics of M · Jul 2013
MOUNTED MEDICAL OXYGEN SYSTEM
K113767 · Essex Industries, Inc. · Jun 2012
PRECISION LIQUID OXYGEN SYSTEM
K103324 · Precision Medical, Inc. · Apr 2011
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
K101272 · Essex Industries, Inc. · Aug 2010
GOLOX-93
K081779 · Respironics, Inc. · Sep 2008
MODIFICATION TO: SPIRIT
K080023 · Caire, Inc. · Jun 2008