[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1400]

[Page 275]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868--ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 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).