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21 C.F.R. § 870.4410 – Cardiopulmonary bypass in-line blood gas sensor. | Midpage
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Code of Federal Regulations
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Subchapter H
Part 870
Subpart E
§ 870.4410
21 C.F.R. § 870.4410
Cardiopulmonary bypass in-line blood gas sensor.
(a)
Identification.
A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.
(b)
Classification.
Class II (performance standards).