21 C.F.R. § 868.2025
Ultrasonic air embolism monitor.
Cite as 21 C.F.R. § 868.2025 (2026)
(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).