[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: 21CFR868.1200]

[Page 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. 868.1200  Indwelling blood oxygen partial pressure (PO2) analyzer.

    (a) Identification. An indwelling blood oxygen partial pressure 
(PO2) analyzer is a device that consists of a catheter-tip 
PO2 transducer (e.g., PO2 electrode) and that is 
used to measure, in vivo, the partial pressure of oxygen 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]