Device Dossier
FALCON PSG - Sleep assessment device
Device Dossier for FALCON PSG - Sleep assessment device (Sleep assessment device, Class IIa, sponsor Compumedics). ARTG record, intended purpose, GMDN…
- GMDN category: Sleep assessment device
Intended purpose
The Falcon PSG is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.