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,…
- GMDN category: Probe, pulse oximeter, single use
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.