Hi Flow Portable Liquid Oxygen Unit

FDA 510(k) K875352 · Minnesota Valley Engineering, Inc.

Substantially Equivalent

510(k) numberK875352

Submission

Device name
Hi Flow Portable Liquid Oxygen Unit
Applicant
Minnesota Valley Engineering, Inc.
New Prague, MN, US
Received
December 31, 1987
Decision date
February 29, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K113767Mounted Medical Oxygen SystemBYJ · Traditional Essex Industries, Inc.06/29/2012SE
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

More from Caire, Inc.

510(k)DeviceDecision
K882328Hi Flow 50BYJ · Traditional 06/28/1988SE
K880101Liberator 53/STROLLER 50BYJ · Traditional 02/29/1988SE
K872449Nomad (Base Unit/Portable Unit)BYJ · Traditional 07/21/1987SE

Questions and answers

When was Hi Flow Portable Liquid Oxygen Unit cleared by the FDA?

Hi Flow Portable Liquid Oxygen Unit (K875352) received a 510(k) decision of Substantially Equivalent on February 29, 1988, 60 days after the submission was received.

What is the product code of K875352?

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