OLF
- Product code
- OLF
- Device name
- Medevac Use Oxygen Generator
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5440
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 1
FDA classification 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.
Official FDA classification page: OLF
Classification and pathway per current FDA publications. Data from openFDA (CC0).