Device Dossier
Spirometer, diagnostic
Device Dossier for Spirometer, diagnostic (Spirometer, diagnostic, Class IIa, sponsor Zone Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Spirometer, diagnostic
Intended purpose
Safey Clinic Spirometer shall be used by Healthcare Professionals licensed by law to perform lung function tests of their patients above 5 years of age. This device is intended to be used under Home Healthcare environment and Professional Healthcare Environment. This device should be used under the instructions of a licensed healthcare professional.