21 CFR 884.2640
§ 884.2640 Fetal phonocardiographic monitor and accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.2640, § 884.2640 Fetal phonocardiographic monitor and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90801
- Permanent ID
ys:prov:90801@1- SHA-256
c6612787ee38712206ed82df0ef5e3413374d24a4077d05009844a8191ecac9b
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.
(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.