---
kind: "section"
citation: "21 C.F.R. § 884.2675"
title: "21"
number: "884.2675"
heading: "Fetal scalp circular (spiral) electrode and applicator."
url: "https://uscodex.org/cfr/21/884.2675"
---

# §884.2675. Fetal scalp circular (spiral) electrode and applicator.

- (a) **Identification.** A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

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

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.