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e-CFR data is current as of February 26, 2021

Title 21Chapter ISubchapter HPart 874Subpart B → §874.1325


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices


§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.

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

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