Code of Federal Regulations · Section

§ 870.4300 — Cardiopulmonary Bypass Gas Control Unit

21 C.F.R. § 870.4300

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(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. § 870.4290 21 C.F.R. § 870.4310

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