Code of Federal Regulations · Section

§ 868.2025 — Ultrasonic Air Embolism Monitor

21 C.F.R. § 868.2025

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(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).

21 C.F.R. § 868.2300

Authorizing Statute