Mobilaire Liquid Oxygen Systems
FDA 510(k) K926267 · Invacare Corp.
510(k) numberK926267
Submission
- Device name
- Mobilaire Liquid Oxygen Systems
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- December 18, 1992
- Decision date
- August 31, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 07/19/2013SE |
| K113767 | Mounted Medical Oxygen SystemBYJ · Traditional | Essex Industries, Inc. | 06/29/2012SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | Precision Medical, Inc. | 04/21/2011SE |
| K101272 | Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional | Essex Industries, Inc. | 08/20/2010SE |
| K081779 | GOLOX-93BYJ · Traditional | Respironics, Inc. | 09/19/2008SE |
| K080023 | Modification to: SpiritBYJ · Special | Caire, Inc. | 06/16/2008SE |
| K072723 | Respironics GoloxBYJ · Traditional | Respironics, Inc. | 03/20/2008SE |
| K072011 | Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional | Copd Partners, Inc. | 10/18/2007SE |
| K071581 | Backpack Medical Oxygen SystemBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 07/11/2007SE |
| K050153 | Spirit, Model HasBYJ · Traditional | Caire, Inc. | 04/15/2005SE |
More from Caire, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203210 | Invacare Platinum 5NXG Oxygen ConcentratorCAW · Traditional | 04/12/2021SE |
| K202379 | Invacare AVIVA Storm RX Power ChairITI · Traditional | 03/19/2021SE |
| K200890 | Invacare Perfecto2V Oxygen ConcentratorCAW · Traditional | 08/06/2020SE |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI · Traditional | 01/02/2020SE |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…CAW · Traditional | 08/29/2019SE |
| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | 12/11/2018SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | 11/14/2018SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | 07/12/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | 04/17/2017SE |
| K162696 | Kuschall Advance Manual WheelchairIOR · Traditional | 12/28/2016SE |
Questions and answers
When was Mobilaire Liquid Oxygen Systems cleared by the FDA?
Mobilaire Liquid Oxygen Systems (K926267) received a 510(k) decision of Substantially Equivalent on August 31, 1993, 256 days after the submission was received.
What is the product code of K926267?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.