Title 21 Part 892 → Subpart B → §892.1540

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1540

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1540

e-CFR data is current as of June 3, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1540

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§892.1540   Nonfetal ultrasonic monitor.

(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.