Device Dossier
Patient monitor, cardiotocograph
Device Dossier for Patient monitor, cardiotocograph (Patient monitor, cardiotocograph, Class IIb, sponsor AMA Medical Products). ARTG record, intended…
- GMDN category: Patient monitor, cardiotocograph
Intended purpose
This device is intended to be used to monitor the physiological parameters of a pregnant woman during antepartum, labour and delivery. It is also intended to provide non-stress testing or foetal monitoring for pregnant women from the 28th week of gestation which includes the monitoring of the foetal heart rate, foetal movement and records direct ECG and uterine activity.