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51 FR 40389, Nov. 6, 1986, unless otherwise noted.
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Subscribe to: 21 CFR 874.1060
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Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.
(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]