K040287 is an FDA 510(k) clearance for the VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on April 26, 2004, 80 days after receiving the submission on February 6, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K040287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2004 |
| Decision Date | April 26, 2004 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |