Device typeObstetrical monitoring/analysis software: A software program intended to facilitate clinical management of pregnancy and/or labour by providing functionality in one or more of the following areas: data acquisition, recording, analysis, and reporting. It typically processes maternal and/or foetal physiologic parameters [e.g., maternal heart rate (MHR) and foetal heart rate (FHR), maternal oxygen saturation (SpO2) and temperature, intrapartum foetal oxygen saturation (FSpO2), intrauterine/amniotic pressure], and is intended to be used in conjunction with specialized monitors in the maternity unit.
FDA categorySystem, Monitoring, Perinatal
Device IDB087CURVE02081
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information