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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR874.5300]
See Related Information on Ear, nose, and throat examination and treatment unit. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 874 -- EAR, NOSE, AND THROAT DEVICES

Subpart F--Therapeutic Devices

Sec. 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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