Device Dossier
Foetal Doppler system
Device Dossier for Foetal Doppler system (Foetal Doppler system, Class IIa, sponsor Parker Healthcare). ARTG record, intended purpose, GMDN category —…
- GMDN category: Foetal Doppler system
Intended purpose
A portable, hand-held, battery-powered device consisting of advanced audio output, optional display and interchangeable foetal and vascular probes for determining foetal viability and peripheral vascular disease. 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.