§ 868.2380. Nitric oxide analyzer.
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/us/cfr/t21/s§ 868.2380·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]