Device Dossier
Oxygen concentrator
Device Dossier for Oxygen concentrator (Stationary oxygen concentrator, Class IIb, sponsor Asia Actual). ARTG record, intended purpose, GMDN category —…
- GMDN category: Stationary oxygen concentrator
Intended purpose
The Oxygen Concentrators are intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.