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21 C.F.R. § 870.4205 – Cardiopulmonary bypass bubble detector. | Midpage
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Subchapter H
Part 870
Subpart E
§ 870.4205
21 C.F.R. § 870.4205
Cardiopulmonary bypass bubble detector.
(a)
Identification.
A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.
(b)
Classification.
Class II (performance standards).