21 C.F.R. § 868.1640

Helium gas analyzer.

Last amended: 2016Year: 2026Length: 44 wordsSubsections: 1Official source

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).
21 C.F.R. § 868.1640: Helium gas analyzer. | Justis AI