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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQE | Catheter, Oximeter, Fiber-Optic | 2 | 19 | 3rd Party |
| NMB | Catheter, Oximeter, Fiber Optic, Reprocessed | 2 | 0 |
