Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor ACRA Regulatory Services). ARTG record, intended purpose, GMDN…
- GMDN category: Spirometer, diagnostic
Intended purpose
A portable spirometer consisting of three parts – a phone app, detector and disposable turbine mouth piece, intended to be used for monitoring lung function capability by measuring the maximal volume (FVC) and flow of air (FEV1) for the detection, assessment and monitoring of certain lung diseases. The spirometer is used to support the diagnosis of respiratory lung diseases when all function results are verified by a lung specialist before any diagnosis or medical treatment is considered or initiated.