21 C.F.R. § 870.1230

Current through September 30, 2024
Section 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).

21 C.F.R. § 870.1230