Device Dossier
Stationary oxygen concentrator
Device Dossier for Stationary oxygen concentrator (Stationary oxygen concentrator, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN…
- GMDN category: Stationary oxygen concentrator
Intended purpose
The Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The device is for use in the home or hospital/institutional environment.