Cardiopulmonary bypass pump speed control.

21 C.F.R. § 870.4380
in effectEffective: 2024-07-01
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(a) Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery. (b) Classification. Class II (performance standards).

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