[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: 21CFR868.2500]

[Page 301]
 
                        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. 868.2500  Cutaneous oxygen (PcO[bdi2]) monitor.

    (a) Identification. A cutaneous oxygen (PcO2) monitor is 
a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) 
placed on the patient's skin that is intended to monitor relative 
changes in the cutaneous oxygen tension.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) 
Monitors; Guidance for Industry and FDA.'' See Sec. 868.1(e) for the 
availability of this guidance document.

[67 FR 76681, Dec. 13, 2002]