OLF · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5440
Classification
FDA Product Code
OLF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5440
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.