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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 884 - Obstetrical and Gynecological Devices |
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Subpart C - Obstetrical and Gynecological Monitoring Devices |
§ 884.2640 - Fetal phonocardiographic monitor and accessories.
Latest version.
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§ 884.2640 Fetal phonocardiographic monitor and accessories.
(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).