Cardiopulmonary bypass level sensing monitor and/or control.

21 C.F.R. § 870.4340
in effectEffective: 2024-07-01
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(a) Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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