---
kind: "section"
citation: "21 C.F.R. § 870.4340"
title: "21"
number: "870.4340"
heading: "Cardiopulmonary bypass level sensing monitor and/or control."
url: "https://uscodex.org/cfr/21/870.4340"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 870.9](/cfr/21/870.9.md).

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]