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§ 868.1400 Carbon dioxide gas analyzer.

21 CFR 868.1400

Citation21 CFR 868.1400
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 868.1400 Carbon dioxide gas analyzer.

(a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

(b) Classification. Class II (performance standards).