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Code of Federal Regulations Title 21. Food and Drugs § 21.884.2675 Fetal scalp circular (spiral) electrode and applicator

Current as of January 02, 2025 | Updated by Findlaw Staff

(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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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.884.2675 Fetal scalp circular (spiral) electrode and applicator - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-884-2675/

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