21 C.F.R. § 870.1230
Fiberoptic oximeter catheter.
Cite as 21 C.F.R. § 870.1230 (2026)
(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).