21 C.F.R. § 868.2380 Nitric oxide analyzer.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart C—Monitoring Devices
§ 868.2380 Nitric oxide analyzer.
