Regulatory Text
21 C.F.R. § 874.3330 — Master hearing aid.
§ 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid. (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]
Source: ecfr.gov · govinfo.gov — public domain
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21 C.F.R. § 874.3330
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The regulatory text of 21 C.F.R. § 874.3330 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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Title 21 — Food and Drugs
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21 C.F.R. — public domain
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