21 C.F.R. § 868.1640 Helium gas analyzer.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 868.1640 Helium gas analyzer.
