View all text of Subpart E [§ 870.4075 - § 870.4885]
§ 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.