[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: 21CFR868.1120]

[Page 296]
 
                        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. 868.1120  Indwelling blood oxyhemoglobin concentration analyzer.

    (a) Identification. An indwelling blood oxyhemoglobin concentration 
analyzer is a photoelectric device used to measure, in vivo, the oxygen-
carrying capacity of hemoglobin in blood to aid in determining the 
patient's physiological status.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 21, 2004, for any indwelling 
blood oxyhemoglobin concentration analyzer that was in commercial 
distribution before May 28, 1976, or that has, on or before September 
21, 2004, been found to be substantially equivalent to an indwelling 
blood oxyhemoglobin concentration analyzer that was in commercial 
distribution before May 28, 1976. Any other indwelling blood 
oxyhemoglobin concentration analyzer shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 
FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004]