21 C.F.R. § 868.2380

Current through September 30, 2024
Section 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."

21 C.F.R. §868.2380

65 FR 14465, Mar. 3, 2000