Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor GE Healthcare). ARTG record, intended purpose, GMDN category —…
- GMDN category: Spirometer, diagnostic
- Sponsor: GE Healthcare
Intended purpose
This device is intended to provide calibration-free spirometry testing and to measure lung air volume and airflow rate independently of gas composition pressure, temperature and humidity.