Mark III Oxygen Walker Sys. Reservoir
FDA 510(k) K832143 · Linde Div. Union Carbide Corp.
510(k) numberK832143
Submission
- Device name
- Mark III Oxygen Walker Sys. Reservoir
- Applicant
- Linde Div. Union Carbide Corp.
Mchenry, IL, US - Received
- July 5, 1983
- Decision date
- August 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K882208 | Mediblend (TM) Medical Laser Gas MixturesGEX · Traditional | 08/03/1988SE |
| K882209 | Mediblend (TM) Clinical Blood Gas MixturesCHL · Traditional | 08/02/1988SE |
| K882210 | Mediblend (TM) Lung Diffusion Gas MixturesBXK · Traditional | 06/21/1988SE |
| K823582 | Oxygen Concentrator UCC-100CAW · Traditional | 01/05/1983SE |
| K821841 | Medigas Suction/Drainage EquipmentGCX · Traditional | 07/02/1982SE |
Questions and answers
When was Mark III Oxygen Walker Sys. Reservoir cleared by the FDA?
Mark III Oxygen Walker Sys. Reservoir (K832143) received a 510(k) decision of Substantially Equivalent on August 26, 1983, 52 days after the submission was received.
What is the product code of K832143?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.