OLF — Medevac Use Oxygen Generator Class II
FDA product code OLF covers "Medevac Use Oxygen Generator", a Class II medical device regulated under 21 CFR 868.5440. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OLF
- Device Class
- Class II
- Regulation Number
- 868.5440
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K082829 | carleton life support systems | AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) | December 22, 2008 |