21 CFR § 870.4220 - Cardiopulmonary bypass heart-lung machine console.
(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).