---
kind: "section"
citation: "21 C.F.R. § 868.2550"
title: "21"
number: "868.2550"
heading: "Pneumotachometer."
url: "https://uscodex.org/cfr/21/868.2550"
---

# §868.2550. Pneumotachometer.

- (a) **Identification.** A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
- (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 [§ 868.9](/cfr/21/868.9.md).

## Notes

### Amendments

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]

### Authority

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

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]
