Liquid Oxygen System
FDA 510(k) K840534 · The John Bunn Co.
510(k) numberK840534
Submission
- Device name
- Liquid Oxygen System
- Applicant
- The John Bunn Co.
Mchenry, IL, US - Received
- February 8, 1984
- Decision date
- March 2, 1984
- 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 |
|---|---|---|
| K900854 | John Bunn: Medix Compact TravellerBTT · Traditional | 04/23/1990SE |
| K883216 | Bunn Model 50 Oxygen Flow ControllerNFB · Traditional | 08/18/1988SE |
| K873071 | Bunn Concentrator Model 2100 SeriesCAW · Traditional | 09/15/1987SE |
| K870094 | Bunn Model 530 AspiratorBTA · Traditional | 03/06/1987SE |
| K861435 | Bunn Concentrator Model 2011 with Demand ValveCAW · Traditional | 11/07/1986SE |
| K861199 | Bunn Model 22 Oxygen Flow ControllerNFB · Traditional | 08/26/1986SE |
| K862628 | Bunn Model 510 Medication CompressorBTI · Traditional | 08/07/1986SE |
| K855208 | Bunn Lite Oxygen ConcentratorCAW · Traditional | 02/21/1986SE |
| K860060 | RX02 Plus Oxygen ConcentratorCAW · Traditional | 02/05/1986SE |
| K843811 | Bunn 3001 Oxygen ConcentratorCAW · Traditional | 10/04/1984SE |
Questions and answers
When was Liquid Oxygen System cleared by the FDA?
Liquid Oxygen System (K840534) received a 510(k) decision of Substantially Equivalent on March 2, 1984, 23 days after the submission was received.
What is the product code of K840534?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.