Portable Liquid Oxygen Unit (Modification)
FDA 510(k) K863978 · Penox Technologies, Inc.
510(k) numberK863978
Submission
- Device name
- Portable Liquid Oxygen Unit (Modification)
- Applicant
- Penox Technologies, Inc.
Pittston, PA, US - Received
- October 14, 1986
- Decision date
- December 15, 1986
- 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 |
|---|---|---|
| K864667 | Penox Hospital BedFNJ · Traditional | 01/21/1987SE |
| K862654 | Modified Penox Lift ChairINO · Traditional | 07/18/1986SE |
| K853775 | Penox High Flow ManifoldBYJ · Traditional | 11/29/1985SE |
| K852109 | Penox Performer WheelchairIOR · Traditional | 08/22/1985SE |
| K851218 | Penox Lift ChairINO · Traditional | 06/21/1985SE |
| K851219 | Fill Hose Safety AdapterCAM · Traditional | 06/18/1985SE |
| K851217 | Penox Dual Flow MinifoldCAM · Traditional | 06/18/1985SE |
| K851216 | Penox Dual Feed ManifoldCAM · Traditional | 06/18/1985SE |
| K851215 | T-Handle Adapter, U-Handle & L Handler AdapterCAM · Traditional | 06/18/1985SE |
Questions and answers
When was Portable Liquid Oxygen Unit (Modification) cleared by the FDA?
Portable Liquid Oxygen Unit (Modification) (K863978) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 62 days after the submission was received.
What is the product code of K863978?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.