Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025
§ 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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
cite as: 21 CFR 870.1230