21 CFR § 870.4330 - Cardiopulmonary bypass on-line blood gas monitor.

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

(b)Classification. Class II (performance standards).