§ 870.4220. Cardiopulmonary bypass heart-lung machine console.
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/us/cfr/t21/s§ 870.4220·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
(b)Classification. Class II (performance standards).