Cleared Traditional

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)

K130068 · Essex Industries, Inc. D/B/A Essex Cryogenics of M · Anesthesiology

Jul 2013

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K130068 is an FDA 510(k) clearance for the DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS), a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Essex Industries, Inc. D/B/A Essex Cryogenics of M (St. Louis, US). The FDA issued a Cleared decision on July 19, 2013, 189 days after receiving the submission on January 11, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number	K130068 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2013
Decision Date	July 19, 2013
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF