Cleared Traditional

GOLOX-93

K081779 · Respironics, Inc. · Anesthesiology
Sep 2008
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K081779 is an FDA 510(k) clearance for the GOLOX-93, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 19, 2008, 88 days after receiving the submission on June 23, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K081779 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2008
Decision Date September 19, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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
MODIFICATION TO: SPIRIT
K080023 · Caire, Inc. · Jun 2008
RESPIRONICS GOLOX
K072723 · Respironics, Inc. · Mar 2008