DeviceClearance

Product code OLF— Anesthesiology

AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)

Classification name
Medevac Use Oxygen Generator
Device class
Class 2
Regulation
21 CFR 868.5440
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OLF under 21 CFR 868.5440, via openFDA

Market context for product code OLF

FDA has cleared 1 device under product code OLF, all in 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OLF

Recent clearances under product code OLF

Data sourced from openFDA. This site is unofficial and independent of the FDA.