21 CFR § 874.5300 - Ear, nose, and throat examination and treatment unit.

---
identifier: "/us/cfr/t21/s874.5300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.5300 - Ear, nose, and throat examination and treatment unit."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.5300"
section_name: "Ear, nose, and throat examination and treatment unit."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 874.5300 Ear, nose, and throat examination and treatment unit.

(a) *Identification.* An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]