21 C.F.R. § 874.5300

Current through September 30, 2024
Section 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 .

21 C.F.R. §874.5300

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