Device Dossier
Audiometer, pure-tone
Device Dossier for Audiometer, pure-tone (Audiometer, pure-tone, Class IIa, sponsor Ecomed). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Audiometer, pure-tone
Intended purpose
Non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing for pediatric and adult patients. The device is not indicated as a sole means of diagnostics.