21 CFR 868.2385
§ 868.2385 Nitrogen dioxide analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.2385, § 868.2385 Nitrogen dioxide analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89756
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.