21 CFR 870.1875
§ 870.1875 Stethoscope.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.1875, § 870.1875 Stethoscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89908
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Full text
(a) Manual stethoscope—(1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
(2) 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 § 870.9.
(b) Electronic stethoscope—(1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.