VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
Device Facts
| Record ID | K000664 |
|---|---|
| Device Name | VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS |
| Applicant | Baxter Healthcare Corp |
| Product Code | DXG · Cardiovascular |
| Decision Date | Sep 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.
