Code of Federal Regulations · Section
§ 870.4205 — Cardiopulmonary Bypass Bubble Detector
21 C.F.R. § 870.4205
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351