21 CFR 884.2600

§ 884.2600 Fetal cardiac monitor.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 884.2600, § 884.2600 Fetal cardiac monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90799
Permanent ID: ys:prov:90799@1
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Full text

(a) Identification. A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the “fetal cardiotachometer (with sensors)” and the “fetal electrocardiographic monitor.” (b) Classification. Class II (performance standards).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.