Device Dossier

Probe, pulse oximeter, reusable

Device Dossier for Probe, pulse oximeter, reusable (Probe, pulse oximeter, reusable, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN…

Intended purpose

Reusable sensors are indicated for either spot check or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor) &/or arterial carboxyhemoglobin saturation (SpCO®) and arterial methemoglobin for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

TGA Public Summary