CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR874.1120]

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 B - Diagnostic Devices

Sec. 874.1120 Electronic noise generator for audiometric testing.

(a) Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

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

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]