21 CFR § 868.1640 - Helium gas analyzer.

§ 868.1640 Helium gas analyzer.

(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).