Code of Federal Regulations · Section
§ 870.1230 — Fiberoptic Oximeter Catheter
21 C.F.R. § 870.1230
View:
(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).
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351