21 C.F.R. § 884.2675

Current through October 31, 2024
Section 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).

21 C.F.R. §884.2675