[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: 21CFR870.1230]

[Page 304]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 870--CARDIOVASCULAR DEVICES--Table of Contents
 
              Subpart B--Cardiovascular Diagnostic Devices
 
Sec. 870.1230  Fiberoptic oximeter catheter.

    (a) Identification. A fiberoptic oximeter catheter is a device used 
to estimate the oxygen saturation of the blood. It consists of two 
fiberoptic bundles that conduct light at a desired wavelength through 
blood and detect the reflected and scattered light at the distal end of 
the catheter.
    (b) Classification. Class II (performance standards).