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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 868Subpart B → §868.1400


Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices


§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).

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