[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1150]

[Page 282]
 
                        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. 868.1150  Indwelling blood carbon dioxide partial pressure (PCO2) analyzer.

    (a) Identification. An indwelling blood carbon dioxide partial 
pressure PCO2 analyzer is a device that consists of a 
catheter-tip PCO2 transducer (e.g., PCO2 
electrode) and that is used to measure, in vivo, the partial pressure of 
carbon dioxide in blood to aid in determining the patient's circulatory, 
ventilatory, and metabolic status.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.''

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]