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e-CFR data is current as of July 1, 2020

Title 21Chapter ISubchapter HPart 874Subpart F → §874.5300


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


§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]

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