21 C.F.R. § 868.1640

Current through October 31, 2024
Section 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).

21 C.F.R. § 868.1640