21 C.F.R. · Food and Drugs
21 C.F.R. § 874.1060

Acoustic chamber for audiometric testing.

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21 C.F.R. § 874.1060 — Acoustic chamber for audiometric testing.

§ 874.1060 Acoustic chamber for audiometric testing. (a) Identification. An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds. (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 the limitations in § 874.9. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001]

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21 C.F.R. § 874.1060
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The regulatory text of 21 C.F.R. § 874.1060 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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