21 C.F.R. § 870.4300

Current through October 31, 2024
Section 870.4300 - Cardiopulmonary bypass gas control unit
(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).

21 C.F.R. § 870.4300