Device Dossier

Patient monitor, cardiotocograph

Device Dossier for Patient monitor, cardiotocograph (Patient monitor, cardiotocograph, Class IIb, sponsor Quintessa Holdings). ARTG record, intended…

Intended purpose

The STAN S41 Maternal and Fetal Monitor is intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing, labor and delivery. It is intended for continuous and auscultatory monitoring of maternal ECG, maternal non-invasive blood pressure (NIBP), maternal oxygen saturation (MSpO2), maternal respiration rate (Resp), uterine activity (UA), fetal movements (FM), and fetal heart rate (FHR) of single fetuses and twins.

TGA Public Summary