eCFR Reference Browser

---

title: "21 CFR §884.2640"

source: "https://www.ecfr.gov/current/title-21/section-884.2640"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "884"

part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"

subpart_code: "C"

subpart_subject: "Obstetrical and Gynecological Monitoring Devices"

section_number: "884.2640"

section_subject: "Fetal phonocardiographic monitor and accessories."

cfr_reference: "21 CFR 884.2640"

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"

---

(a)Identification. A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.

(b)Classification. Class II (performance standards).

§884.2640 - Fetal phonocardiographic monitor and accessories.