Device Dossier

Probe, pulse oximeter, single use

Device Dossier for Probe, pulse oximeter, single use (Probe, pulse oximeter, single use, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…

Intended purpose

A photoelectric device applied externally to a body site, e.g., a fingertip, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters. This is a single-use device.

TGA Public Summary