FDA Product Code HGM: System, Monitoring, Perinatal

Continuous fetal monitoring enables early detection of fetal compromise during labor. FDA product code HGM covers perinatal monitoring systems.

These systems simultaneously record fetal heart rate and uterine contractions via external Doppler and tocodynamometer transducers, providing a continuous cardiotocograph for the assessment of fetal wellbeing and labor progress.

HGM devices are Class II medical devices, regulated under 21 CFR 884.2740 and reviewed by the FDA Obstetrics & Gynecology panel.

Leading manufacturers include Huntleigh Healthcare , Ltd., Edan Instruments, Inc. and Sibel Health, Inc..