Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor Intervene Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Spirometer, diagnostic
Intended purpose
The PumlOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes, and diffusing capacity. The PulmOne MiniBox+ is to be used by a physician respiratory therapist, or technician in a hospital or clinic setting.