§ 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.