§ 884.2675. Fetal scalp circular (spiral) electrode and applicator.
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/us/cfr/t21/s§ 884.2675·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).