Device Dossier
Pulse oximeter, battery-powered
Device Dossier for Pulse oximeter, battery-powered (Pulse oximeter, battery-powered, Class IIa, sponsor Share Info). ARTG record, intended purpose, GMDN…
- GMDN category: Pulse oximeter, battery-powered
Intended purpose
The Pulse Oximeter is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data storage, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals(except the operating room, ICU) and home use.