Device Dossier
Sleep assessment device
Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor BMedical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Sleep assessment device
Intended purpose
The device is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals during wake or sleep periods and is intended for use for the diagnostic evaluation by a physician and to be used under the supervision of a clinician to assess sleep quality and score sleep disordered breathing events in adults only.