Device Dossier

Spirometer, diagnostic

Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor DocStock). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

Spirometry handle is intended to be used with the ECG analysis system for prescription use only to perform spirometry diagnostic tests in adults and paediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used to measure patient respiratory parameters including FVC, COPD, SVC, MVV.

TGA Public Summary