21 CFR 884.2720 - External uterine contraction monitor and accessories.

§ 884.2720 External uterine contraction monitor and accessories.

(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).

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