[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: 21CFR868.1150]

[Page 271-272]
 
                        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

[[Page 272]]

dioxide in blood to aid in determining the patient's circulatory, 
ventilatory, and metabolic status.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 868.3.

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