Cleared Traditional

MARK III OXYGEN WALKER SYS-LOW PRESS

K830337 · Union Carbide Corp. · Anesthesiology
Mar 1983
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K830337 is an FDA 510(k) clearance for the MARK III OXYGEN WALKER SYS-LOW PRESS, 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 17, 1983, 44 days after receiving the submission on February 1, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K830337 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1983
Decision Date March 17, 1983
Days to Decision 44 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