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

Software application intended for physiological signal retrieval, visualisation, report generation, automated analysis and interpretation for the area of direct diagnosis and monitoring of obstructive sleep apnoea, including SpO2 software module: to optionally derive Oxygen Saturation level from the own manufactured electronic reflective photo plethysmogram (PPG) sensor.

TGA Public Summary