Device Dossier
Probe, pulse oximeter, reusable
Device Dossier for Probe, pulse oximeter, reusable (Probe, pulse oximeter, reusable, Class IIb, sponsor Mediris). ARTG record, intended purpose, GMDN…
- GMDN category: Probe, pulse oximeter, reusable
Intended purpose
A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as arterial oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection.The device is reusable.