21 C.F.R. § 884.2720 External uterine contraction monitor and accessories.
Title 21 - Food and Drugs
(a) Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart C—Obstetrical and Gynecological Monitoring Devices
§ 884.2720 External uterine contraction monitor and accessories.
