Device Dossier

Sleep assessment device

Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Digital Dental Resources). ARTG record, intended purpose, GMDN…

Intended purpose

A device intended for the registration of physiological signals from a patient while sleeping and used for assessing and aiding in the treatment of sleeping disorders, e.g. insomnia, snoring or sleep apnoea. Sensors include oxygen saturation, heart rate, pressure flow, chest and abdomen movement, body position, EKG, EMG and audio levels. The device is mobile and can be used in a patient's home or a medical or dental environment.

TGA Public Summary