BYJ — Unit, Liquid-Oxygen, Portable Class II
FDA product code BYJ covers "Unit, Liquid-Oxygen, Portable", a Class II medical device regulated under 21 CFR 868.5655. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYJ
- Device Class
- Class II
- Regulation Number
- 868.5655
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130068 | essex industries, inc. d/b/a essex cryogenics of m | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) | July 19, 2013 |
| K113767 | essex industries | MOUNTED MEDICAL OXYGEN SYSTEM | June 29, 2012 |
| K103324 | precision medical | PRECISION LIQUID OXYGEN SYSTEM | April 21, 2011 |
| K101272 | essex industries | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | August 20, 2010 |
| K081779 | respironics | GOLOX-93 | September 19, 2008 |
| K080023 | caire | MODIFICATION TO: SPIRIT | June 16, 2008 |
| K072723 | respironics | RESPIRONICS GOLOX | March 20, 2008 |
| K072011 | copd partners | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | October 18, 2007 |
| K071581 | essex cryogenics of missouri | BACKPACK MEDICAL OXYGEN SYSTEM | July 11, 2007 |
| K050153 | caire | SPIRIT, MODEL HAS | April 15, 2005 |
| K050414 | respironics | PLIX | April 11, 2005 |
| K041122 | precision medical | PRECISION LIQUID OXYGEN SYSTEM | October 4, 2004 |
| K032143 | micro technology services | LIQUID OXYGEN SYSTEM | March 30, 2004 |
| K033000 | essex cryogenics of missouri | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | March 22, 2004 |
| K013251 | caire | SPIRIT 300 | December 18, 2001 |
| K993220 | puritan bennett | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | October 22, 1999 |
| K971545 | healthdyne technologies | PROTEGE LIQUID OXYGEN SYSTEM | July 25, 1997 |
| K963956 | southern research | PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT | December 9, 1996 |
| K941819 | hogan and hartson | LIQUID OXYGEN STORAGE SUBSYSTEM | May 23, 1994 |
| K933930 | puritan bennett | PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT | March 21, 1994 |