21 CFR 870.4340
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4340, § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90002
- Permanent ID
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848e99e60f5fdcfad5983392371fc182e44c72b8098e7f95f8c2545b308676bd
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.