21 CFR 868.2380
§ 868.2380 Nitric oxide analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.2380, § 868.2380 Nitric oxide analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89755
- Permanent ID
ys:prov:89755@1- SHA-256
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Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.