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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 874—EAR, NOSE, AND THROAT DEVICES > SUBPART B—Diagnostic Devices (§874.1050 to §874.1925) > 874.1050—Audiometer.

CFR

874.1050—Audiometer.

(a) Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
(b) Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.

Code of Federal Regulations

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]
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