Device Dossier

Home CPAP unit

Device Dossier for Home CPAP unit (Home CPAP unit, Class IIa, sponsor ACRA Regulatory Services). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

A portable, single user, reusable device intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, to support treatment of adults weighing over 30 kg (66 lbs) with obstructive sleep apnea (OSA). CAPA tube and tube adaptor provided with CPAP unit

TGA Public Summary