Device Dossier

Probe, pulse oximeter, single use

Device Dossier for Probe, pulse oximeter, single use (Probe, pulse oximeter, single use, Class IIb, sponsor Natus Neuro). ARTG record, intended purpose,…

Intended purpose

31658 - Pulse oximeter probe, single-use A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of hemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device.

TGA Public Summary