21 CFR 884.2640 - Fetal phonocardiographic monitor and accessories.
(a)Identification. A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.
(b)Classification. Class II (performance standards).