Device Dossier

Sleep disorder interpretive software, professional-use

Device Dossier for Sleep disorder interpretive software, professional-use (Sleep disorder interpretive software, professional-use, Class IIa, sponsor…

Intended purpose

A Software as a Medical Device (SaMD) that analyzes physiological signals collected during sleep or wake from compatible third-party devices. It displays signals and data for review by healthcare professionals to aid in the diagnosis of sleep, respiratory, and other disorders. It is intended for use by and on order of a healthcare professional.

TGA Public Summary