---
kind: "section"
citation: "21 C.F.R. § 868.2380"
title: "21"
number: "868.2380"
heading: "Nitric oxide analyzer."
url: "https://uscodex.org/cfr/21/868.2380"
---

# §868.2380. Nitric oxide analyzer.

- (a) **Identification.** The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.
- (b) **Classification.** Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

## Notes

### Amendments

[65 FR 14465, Mar. 3, 2000]

### 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

[65 FR 14465, Mar. 3, 2000]