---
kind: "section"
citation: "21 C.F.R. § 868.1850"
title: "21"
number: "868.1850"
heading: "Monitoring spirometer."
url: "https://uscodex.org/cfr/21/868.1850"
---

# §868.1850. Monitoring spirometer.

- (a) **Identification.** A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
- (b) **Classification.** Class II (performance standards).

## Notes

### 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.