§ 868.5165. Nitric oxide administration apparatus.
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/us/cfr/t21/s§ 868.5165·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
(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 11465, Mar. 3, 2000]