Device Dossier

Hand Held Dopplers - Foetal Doppler system

Device Dossier for Hand Held Dopplers - Foetal Doppler system (Foetal Doppler system, Class IIa, sponsor Arjo). ARTG record, intended purpose, GMDN…

Intended purpose

The Fetal Doppler is indicated for the detection of fetal life, at early gestation from as early as 8 to 10 weeks and for fetal screening from early gestation through to delivery. It provides an audible fetal heart sound and a numeric/graphical display of fetal heart rate.This device is intended for use by qualified healthcare professionals in hospital, clinical environments, and community/home care settings. It is not intended for over-the-counter sale to patients, nor for use by laypersons in any setting.

TGA Public Summary