---
kind: "section"
citation: "21 C.F.R. § 870.2360"
title: "21"
number: "870.2360"
heading: "Electrocardiograph electrode."
url: "https://uscodex.org/cfr/21/870.2360"
---

# §870.2360. Electrocardiograph electrode.

- (a) **Identification.** An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
- (b) **Classification.** Class II (special 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). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See [§ 870.1(e)](/cfr/21/870.1.md?p=e) for availability information of guidance documents.

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585, July 21, 2011]

### 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 76 FR 43585, July 21, 2011]