OLF

Medevac Use Oxygen Generator

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OLF
Classification and pathway per current FDA publications. Data from openFDA (CC0).