Device Dossier

Pulse oximeter, battery-powered

Device Dossier for Pulse oximeter, battery-powered (Pulse oximeter, battery-powered, Class IIa, sponsor Health One). ARTG record, intended purpose, GMDN…

Intended purpose

This is a portable battery powered device intended to provide non-invasive intermittent measurement of oxygen saturation (SpO2) of haemoglobin, the heart rate (PRbpm) and the perfusion index (PI). This device is suitable for private use (at home) as well as for use in the healthcare facilities (hospitals, emergency services, medical establishments).

TGA Public Summary