Modification to: Spirit
FDA 510(k) K080023 · Caire, Inc.
510(k) numberK080023
Submission
- Device name
- Modification to: Spirit
- Applicant
- Caire, Inc.
Marietta, GA, US - Received
- January 4, 2008
- Decision date
- June 16, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K050414 | PlixBYJ · Traditional | Respironics, Inc. | 04/11/2005SE |
More from Respironics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort)CAW · Traditional | 07/11/2025SE |
| K120785 | Omni 3 Oxygen SystemCAW · Special | 10/25/2012SE |
| K121167 | Caire Companion 5 Oxygen ConcentratorCAW · Traditional | 05/02/2012SE |
| K050153 | Spirit, Model HasBYJ · Traditional | 04/15/2005SE |
| K013251 | Spirit 300BYJ · Traditional | 12/18/2001SE |
| K952268 | Model Delta, Om Oxygen ConcentratorCAW · Traditional | 08/11/1995SE |
Questions and answers
When was Modification to: Spirit cleared by the FDA?
Modification to: Spirit (K080023) received a 510(k) decision of Substantially Equivalent on June 16, 2008, 164 days after the submission was received.
What is the product code of K080023?
The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.