{"data":{"id":"us/21-cfr-868.1640","jurisdiction":"us","citation":"21 CFR 868.1640","heading":"Helium gas analyzer.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8162a8ca60687b5c0a5cfcb4bff3813b8434c1e4a82edb300002e50027bb1588","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.1620","next":"us/21-cfr-868.1670"},"notice":"GroundRules: Original legal text. Not legal advice."}