Device Dossier
Home CPAP unit
Device Dossier for Home CPAP unit (Home CPAP unit, Class IIa, sponsor Taevas Life Sciences). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Home CPAP unit
- Sponsor: Taevas Life Sciences
Intended purpose
Positive Airway Pressure Units are indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients weighing more than 66 lb (30 kg). They are intended for home and hospital/institutional use.