21 C.F.R. § 868.1640
Helium gas analyzer.
Cite as 21 C.F.R. § 868.1640 (2026)
(a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry. (b) Classification. Class II (performance standards).