21 CFR 870.1230
§ 870.1230 Fiberoptic oximeter catheter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.1230, § 870.1230 Fiberoptic oximeter catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89877
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.