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45 FR 12684, Feb. 26, 1980, unless otherwise noted.
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(a) Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.
(b) Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]