e-CFR data is current as of February 25, 2021 |
Title 21 → Chapter I → Subchapter H → Part 868 → Subpart B → §868.1075 |
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
(a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
(b) Classification. Class II (performance standards).