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…
- GMDN category: Foetal Doppler system
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.