U.S. Code of Federal Regulations
Regulations most recently checked for updates: Oct 07, 2025
(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).