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 manages data transfer between third-party devices and clinical systems. It analyzes sound recording data from compatible third-party devices for use 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