Regulatory Text
21 C.F.R. § 868.2380 — Nitric oxide analyzer.
§ 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.” [65 FR 14465, Mar. 3, 2000]
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Citation
21 C.F.R. § 868.2380
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The regulatory text of 21 C.F.R. § 868.2380 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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