21 CFR § 868.2385 - Nitrogen dioxide analyzer.

---
identifier: "/us/cfr/t21/s868.2385"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.2385 - Nitrogen dioxide analyzer."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.2385"
section_name: "Nitrogen dioxide analyzer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.2385 Nitrogen dioxide analyzer.

(a) *Identification.* The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide.

(b) *Classification.* Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.

[65 FR 11465, Mar. 3, 2000, as amended at 84 FR 71811, Dec. 30, 2019]