Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025
§ 868.2025 - Ultrasonic air embolism monitor.

(a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.

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

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 47 FR 31142, July 16, 1982, unless otherwise noted.
cite as: 21 CFR 868.2025