21 CFR 874.1060
§ 874.1060 Acoustic chamber for audiometric testing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1060, § 874.1060 Acoustic chamber for audiometric testing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90193
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.