21 CFR § 870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.

§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.

(a)Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.

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