SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
Device Facts
| Record ID | K905458 |
|---|---|
| Device Name | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER |
| Applicant | Baxter Healthcare Corp |
| Product Code | DQE · Cardiovascular |
| Decision Date | Feb 7, 1991 |
| 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.
