21 C.F.R. § 892.1540 Nonfetal ultrasonic monitor.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1540 Nonfetal ultrasonic monitor.
