Device Dossier

Pulmonary function analysis system, adult

Device Dossier for Pulmonary function analysis system, adult (Pulmonary function analysis system, adult, Class IIa, sponsor MGC Diagnostics). ARTG…

Intended purpose

'Intended for measuring pulmonary function in spontaneously breathing patients. The Exhalyzer D system is suited for testing neonates, infants, paediatric and adult patients. The Exhalyzer D includes the following pulmonary function tests: exhaled nitric oxide (all ages), breath by breath monitoring of exhaled Carbon dioxide and oxygen (all ages) and the Multiple-Breath Washout test for lung volumes and ventilation distribution (using sulphur hexafluoride for neonates and infants and 100% oxygen in paediatric and adult ages). The interpretation of the results are the responsibility of the specialist clinician.'

TGA Public Summary