Cardiopulmonary bypass heart-lung machine console.

21 C.F.R. § 870.4220
in effectEffective: 2024-07-01
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(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).

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