eCFR Reference Browser

---

title: "21 CFR §870.1875"

source: "https://www.ecfr.gov/current/title-21/section-870.1875"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "B"

subpart_subject: "Cardiovascular Diagnostic Devices"

section_number: "870.1875"

section_subject: "Stethoscope."

cfr_reference: "21 CFR 870.1875"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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 (performance standards).

§870.1875 - Stethoscope.