GroundRules
21 CFR 868.1640: Helium gas analyzer.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 868—ANESTHESIOLOGY DEVICES
- Subpart B—Diagnostic Devices
(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).
Collected 2026-08-27T02:24:47Z. Source file · JSON