21 C.F.R. § 870.4205
Cardiopulmonary bypass bubble detector.
Cite as 21 C.F.R. § 870.4205 (2026)
(a) Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards).