Device Dossier

Foetal Doppler system

Device Dossier for Foetal Doppler system (Foetal Doppler system, Class IIa, sponsor Ebos Group). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

A hand-held, battery-powered device consisting of a measuring and display unit and probe designed to detect foetal heart beats using ultrasound/Doppler technology with colour display. This device is intended for use by qualified healthcare professionals within hospital or clinical environments. It is not intended for over-the-counter sale or use in home settings by consumers, without the supervision of a qualified healthcare professional.

TGA Public Summary