Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor Intermed Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Spirometer, diagnostic
- Sponsor: Intermed Medical
Intended purpose
This is a device that is intended to be used to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. The flow/volume measurement, in- and expiratory vital capacity, partial volumes, second-volume FEV1, maximum voluntary ventilation MVV, peak-flow and more than 40 sub-parameters These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's former values.