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§ 870.4300 Cardiopulmonary bypass gas control unit.

21 CFR 870.4300

Citation21 CFR 870.4300
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 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).