Regulatory Text
21 C.F.R. § 870.4340 — Cardiopulmonary bypass level sensing monitor and/or control.
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control. (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. [45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]
Source: ecfr.gov · govinfo.gov — public domain
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Citation
21 C.F.R. § 870.4340
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The regulatory text of 21 C.F.R. § 870.4340 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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21 C.F.R. — public domain
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