Device Dossier

HealthGear SleepZone C2 (CPAP) and C5 (Auto) Sleep Apnea Therapy Devices - Home CPAP unit

Device Dossier for HealthGear SleepZone C2 (CPAP) and C5 (Auto) Sleep Apnea Therapy Devices - Home CPAP unit (Home CPAP unit, Class IIa, sponsor Wiselink…

Intended purpose

This device is suitable for non-invasive ventilation of patients with obstructive sleep apnea and chronic obstructive pulmonary disease(COPD). It is used for the pediatric patients aged over 7 (with a weight being over 18.lkg or 40lbs) and adult patients (with a weight being over 30kg and 66lbs) only.

TGA Public Summary