21 CFR 884.2675 - Fetal scalp circular (spiral) electrode and applicator.

§ 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).

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