21 C.F.R. § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
