21 C.F.R. § 870.1230

Fiberoptic oximeter catheter.

Last amended: 2016Year: 2026Length: 53 wordsSubsections: 1Official source

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).
21 C.F.R. § 870.1230: Fiberoptic oximeter catheter. | Justis AI