21 C.F.R. § 868.1690 – Nitrogen gas analyzer. | Midpage
§ 868.1690
21 C.F.R. § 868.1690
Nitrogen gas analyzer.
(a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.
(b) Classification. Class II (performance standards).