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Medevac Use Oxygen Generator

FDA product code OLF · 1 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5440
Review panel
AN
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2008-12-22 – 2008-12-22

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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