Cleared Traditional

RESPIRONICS GOLOX

K072723 · Respironics, Inc. · Anesthesiology
Mar 2008
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K072723 is an FDA 510(k) clearance for the RESPIRONICS GOLOX, 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 March 20, 2008, 176 days after receiving the submission on September 26, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K072723 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2007
Decision Date March 20, 2008
Days to Decision 176 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

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