Device Dossier

Pulse oximeter, battery-powered

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

Intended purpose

This device is intended for use for measuring transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and also measures/displays pulse rate. It is applied to the fingertip and it is intended to be operated by layperson and healthcare providers.

TGA Public Summary