21 CFR § 884.2720 Obstetrical and Gynecological Devices

§ 884.2720 External uterine contraction monitor and accessories.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.2700 Intrauterine pressure monitor and accessories.§ 884.2730 Home uterine activity monitor. →