Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor Innervate). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Spirometer, diagnostic
Intended purpose
The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing or to track lung health on adult and paediatric patients in professional settings starting at age 4, or in the home use environment starting at age 5. The EasyOne Sky spirometer is used by patients, general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinics, pharmacies, in clinical settings in occupational medicine, as well as by patients in a home healthcare environment.