[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1640]

[Page 297]
 
                        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. 868.1640  Helium gas analyzer.

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