Mounted Medical Oxygen System

FDA 510(k) K113767 · Essex Industries, Inc.

Substantially Equivalent

510(k) numberK113767

Submission

Device name
Mounted Medical Oxygen System
Applicant
Essex Industries, Inc.
St. Louis, MO, US
Received
December 21, 2011
Decision date
June 29, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Expedited review
Yes

Official FDA 510(k) record

Device classification

Product code
BYJ – Unit, Liquid-Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5655
Specialty
Anesthesiology

Other 510(k)s with product code BYJ

510(k)DeviceApplicantDecision
K130068Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional Essex Industries, Inc. D/B/A Essex Cryogenics of M07/19/2013SE
K103324Precision Liquid Oxygen SystemBYJ · Traditional Precision Medical, Inc.04/21/2011SE
K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional Essex Industries, Inc.08/20/2010SE
K081779GOLOX-93BYJ · Traditional Respironics, Inc.09/19/2008SE
K080023Modification to: SpiritBYJ · Special Caire, Inc.06/16/2008SE
K072723Respironics GoloxBYJ · Traditional Respironics, Inc.03/20/2008SE
K072011Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional Copd Partners, Inc.10/18/2007SE
K071581Backpack Medical Oxygen SystemBYJ · Traditional Essex Cryogenics of Missouri, Inc.07/11/2007SE
K050153Spirit, Model HasBYJ · Traditional Caire, Inc.04/15/2005SE
K050414PlixBYJ · Traditional Respironics, Inc.04/11/2005SE

More from Respironics, Inc.

510(k)DeviceDecision
K162811MR Conditional CGA 870CAN · Traditional 03/02/2017SE
K161472Walk-O2-BoutECX · Traditional 11/18/2016SE
K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional 08/20/2010SE

Questions and answers

When was Mounted Medical Oxygen System cleared by the FDA?

Mounted Medical Oxygen System (K113767) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 191 days after the submission was received.

What is the product code of K113767?

The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.