[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: 21CFR868.2385]

[Page 279]
 
                        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 C--Monitoring Devices
 
Sec. 868.2385  Nitrogen dioxide analyzer.

    (a) Identification. The nitrogen dioxide analyzer is a device 
intended to measure the concentration of nitrogen dioxide in respiratory 
gas mixtures during administration of nitric oxide.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

[65 FR 11465, Mar. 3, 2000]