OLF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Medevac Use Oxygen Generator

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5440

Medical specialty

Anesthesiology

Flags

Life-sustaining

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.

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