Device Dossier

Stationary oxygen concentrator

Device Dossier for Stationary oxygen concentrator (Stationary oxygen concentrator, Class IIb, sponsor Share Info). ARTG record, intended purpose, GMDN…

Intended purpose

The intended use of the MIC CP501/CP101/AI-5/AII-5 oxygen concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.