{"data":{"id":"us/21-cfr-884.2675","jurisdiction":"us","citation":"21 CFR 884.2675","heading":"Fetal scalp circular (spiral) electrode and applicator.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart C—Obstetrical and Gynecological Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6a44c4245f9894f0ac5d0d4871243bff99b333db72eea7539b2ed17cf0c7e6ee","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.2660","next":"us/21-cfr-884.2685"},"notice":"GroundRules: Original legal text. Not legal advice."}