Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor PulmonX). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Spirometer, diagnostic
Intended purpose
The console is to be used with the Chartis catheter during a diagnostic bronchoscopy in adult patients with chronic obstructive pulmonary disease and emphysema. The system is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments.