Device Dossier
Portable ventilator, electric
Device Dossier for Portable ventilator, electric (Portable ventilator, electric, Class IIb, sponsor Philips Electronics). ARTG record, intended purpose,…
- GMDN category: Portable ventilator, electric
Intended purpose
The device is intended to provide non-invasive ventilatory support to treat adult patients weighing over 30 kg (66 lbs) and pediatric patients 7 years or older and weighing over 18 kg (40 lbs) with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency.This device may be used in the hospital or home.