21 C.F.R. § 870.4300

Cardiopulmonary bypass gas control unit.

Last amended: 2016Year: 2026Length: 37 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 870.4300 (2026)

(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: Cardiopulmonary bypass gas control unit. | Justis AI