Mass Oxygen Distribution System (Mods) Model 10C-0061-3

FDA 510(k) K101272 · Essex Industries, Inc.

Substantially Equivalent

510(k) numberK101272

Submission

Device name
Mass Oxygen Distribution System (Mods) Model 10C-0061-3
Applicant
Essex Industries, Inc.
St. Louis, MO, US
Received
May 6, 2010
Decision date
August 20, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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K130068Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional Essex Industries, Inc. D/B/A Essex Cryogenics of M07/19/2013SE
K113767Mounted Medical Oxygen SystemBYJ · Traditional Essex Industries, Inc.06/29/2012SE
K103324Precision Liquid Oxygen SystemBYJ · Traditional Precision Medical, Inc.04/21/2011SE
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
K113767Mounted Medical Oxygen SystemBYJ · Traditional 06/29/2012SE

Questions and answers

When was Mass Oxygen Distribution System (Mods) Model 10C-0061-3 cleared by the FDA?

Mass Oxygen Distribution System (Mods) Model 10C-0061-3 (K101272) received a 510(k) decision of Substantially Equivalent on August 20, 2010, 106 days after the submission was received.

What is the product code of K101272?

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