Code of Federal Regulations · Section

§ 870.1230 — Fiberoptic Oximeter Catheter

21 C.F.R. § 870.1230

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(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