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…
- GMDN category: Sleep assessment device
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.