OLFClass II
Medevac Use Oxygen Generator
21 CFR 868.5440 / Anesthesiology
OLF is the FDA product code for Medevac Use Oxygen Generator, a class II device type, regulated under 21 CFR 868.5440. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OLF
- Device name
- Medevac Use Oxygen Generator
- FDA 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.
- Regulation
- 21 CFR 868.5440
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OLF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
Applicants with the most clearances
Product code OLF| Applicant | Clearances |
|---|---|
| Mission Systems Davenport Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.