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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1540
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class II.