Fetal scalp circular (spiral) electrode and applicator.

21 C.F.R. § 884.2675
in effectEffective: 2024-07-01
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(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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