Device Dossier
Pulse oximeter, battery-powered
Device Dossier for Pulse oximeter, battery-powered (Pulse oximeter, battery-powered, Class IIa, sponsor A & D). ARTG record, intended purpose, GMDN…
- GMDN category: Pulse oximeter, battery-powered
Intended purpose
The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home use environments. This device is not intended for continuous monitoring. The device can be used multiple times. Pulse oximeter intended for wellness use.