21 C.F.R. § 870.4300 Cardiopulmonary bypass gas control unit.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4300 Cardiopulmonary bypass gas control unit.
