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21 C.F.R. · Food and Drugs
21 C.F.R. § 874.3400

Tinnitus masker.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 874.3400 — Tinnitus masker.

§ 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech. (b) Classification. Class II. The special control for this device is patient labeling regarding: (1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-CE228F
Entity Class
REGULATION / FEDERAL-CFR-SECTION
Domain Signature
boisestandard.org
Citation
21 C.F.R. § 874.3400
Corpus
CFR — Code of Federal Regulations
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✓ ACTIVE
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PRIMARY-SOURCE
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✓ TRUE
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29e548f53df76fdd...
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Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 874.3400 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.
Navigate Corpus — Title 21 C.F.R.
← 21 C.F.R. § 874.3375 21 C.F.R. § 874.3430 →
Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain ← All Legislation
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boisestandard.org → United States → Law → CFR → Title 21 → 21 C.F.R. § 874.3400