Section 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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9 .45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812 , Dec. 30, 2019