OPTICATH
Device Facts
| Record ID | K820674 |
|---|---|
| Device Name | OPTICATH |
| Applicant | Oximetrix, Inc. |
| Product Code | DQE · Cardiovascular |
| Decision Date | Mar 25, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1230 |
| Device Class | Class 2 |
Regulatory Classification
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.
