---
kind: "section"
citation: "21 C.F.R. § 870.1875"
title: "21"
number: "870.1875"
heading: "Stethoscope."
url: "https://uscodex.org/cfr/21/870.1875"
---

# §870.1875. Stethoscope.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 870.9](/cfr/21/870.9.md).
- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 870.9](/cfr/21/870.9.md).

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]