21 CFR 874.5300 — Unit, Examining/Treatment, Ent

Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5300

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.

Classification Rationale

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.

Product Codes