[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.2480]

[Page 276]
 
                        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. 868.2480  Cutaneous carbon dioxide (PcCO2) monitor.

    (a) Identification. A cutaneous carbon dioxide (PcCO2) 
monitor is a noninvasive heated sensor and a pH-sensitive glass 
electrode placed on a patient's skin, which is intended to monitor 
relative changes in a hemodynamically stable patient's cutaneous carbon 
dioxide tension as an adjunct to arterial carbon dioxide tension 
measurement.
    (b) Classification. Class II (performance standards).

[54 FR 27160, June 28, 1989]