21 C.F.R. § 884.2675 Fetal scalp circular (spiral) electrode and applicator.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart C—Obstetrical and Gynecological Monitoring Devices
§ 884.2675 Fetal scalp circular (spiral) electrode and applicator.
