21 CFR 874.1325
§ 874.1325 Electroglottograph.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1325, § 874.1325 Electroglottograph, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90199
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Full text
(a) Identification. An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.