Cleared Traditional Expedited

MOUNTED MEDICAL OXYGEN SYSTEM

K113767 · Essex Industries, Inc. · Anesthesiology

Jun 2012

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K113767 is an FDA 510(k) clearance for the MOUNTED MEDICAL OXYGEN SYSTEM, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 29, 2012, 191 days after receiving the submission on December 21, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number	K113767 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2011
Decision Date	June 29, 2012
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF