Device Dossier

Cardiotocograph - CTG - Patient monitor, cardiotocograph

Device Dossier for Cardiotocograph - CTG - Patient monitor, cardiotocograph (Patient monitor, cardiotocograph, Class IIb, sponsor Rosisi Pty Ltd ATF…

Intended purpose

Intended Purpose statement for Cardiotocograph (CTG). This device is intended to be used by qualified Healthcare professionals for Non-Invasive monitoring, recording and assessment of Fetal Heart rate ( FHR)and Uterine Contractions during the antepartum periods. The Cardiotocograph assist in the evaluation of the fetal wellbeing, the uterine activity aiding in the detection of the potential fetal distress or abnormal labor patterns. It is designed for use in the Clinical settings such as Hospital, Maternity Clinicals and other Healthcare facilities.

TGA Public Summary