Device Dossier
Probe, pulse oximeter, reusable
Device Dossier for Probe, pulse oximeter, reusable (Probe, pulse oximeter, reusable, Class IIb, sponsor Lowenstein Medical). ARTG record, intended…
- GMDN category: Probe, pulse oximeter, reusable
Intended purpose
The reusable pulse oximetry sensor is intended for the continuous, non-invasive or spot-check monitoring of functional arterial oxygen saturation (SpO?) and pulse rate when used with compatible and approved pulse oximeters or oximetry modules. The sensor is intended for use in hospitals, hospital-type facilities, outpatient clinics and emergency medical services by appropriately trained healthcare professionals. The sensor is intended for use on patients in accordance with the specified patient size and application site and must only be used under the conditions described in the system technical documentation.