part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "C"
subpart_subject: "Obstetrical and Gynecological Monitoring Devices"
section_number: "884.2675"
section_subject: "Fetal scalp circular (spiral) electrode and applicator."
cfr_reference: "21 CFR 884.2675"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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).