21 CFR 870.1230 — Catheter, Oximeter, Fiber-Optic

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1230

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DQECatheter, Oximeter, Fiber-Optic2193rd Party
NMBCatheter, Oximeter, Fiber Optic, Reprocessed20
Innolitics

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