21 CFR 870.4300 - Cardiopulmonary bypass gas control unit.

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 870: CARDIOVASCULAR DEVICES

Subpart E: Cardiovascular Surgical Devices

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).

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