NMB · Catheter, Oximeter, Fiber Optic, Reprocessed
Cardiovascular · 21 CFR 870.1230 · Class 2
Overview
| Product Code | NMB |
|---|---|
| Device Name | Catheter, Oximeter, Fiber Optic, Reprocessed |
| Regulation | 21 CFR 870.1230 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
