21 C.F.R. § 874.1325

Current through October 31, 2024
Section 874.1325 - Electroglottograph
(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 .

21 C.F.R. §874.1325

51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813 , Dec. 30, 2019