Device Dossier
Audiometer, impedance
Device Dossier for Audiometer, impedance (Audiometer, impedance, Class IIa, sponsor Welch Allyn). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Audiometer, impedance
Intended purpose
The device is an auditory impedance tester intended to detect possible otologic disorders associated with the functioning of the middle ear. It is intended to be used in a hospital, clinic or other healthcare facility with a suitable quiet testing environment such as a private exam room.