Device Dossier
Sleep assessment device
Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Compumedics). ARTG record, intended purpose, GMDN category —…
- GMDN category: Sleep assessment device
Intended purpose
The Compumedics Somté PSG Recording System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle actively, eye movement, breathing and body movements to assist in the diagnosis of various sleep related disorders. The Compumedics Somté PSG Recording System is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Compumedics Somté PSG Recording System is only to be used under the direction of a physician.