The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Vigilance Continuous Cardiac Output/oximetry/continuous End Diastolic Volume (cc0/svo2/cedv) Monitor.
| Device ID | K040287 |
| 510k Number | K040287 |
| Device Name: | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Paula A Torrianni |
| Correspondent | Paula A Torrianni EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2004-04-26 |
| Summary: | summary |