The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Modification To Vigileo Arterial Pressure Cardiac Output/oximetry Monitor.
| Device ID | K082308 |
| 510k Number | K082308 |
| Device Name: | MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason Smith |
| Correspondent | Jason Smith 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 | 2008-08-13 |
| Decision Date | 2008-12-09 |
| Summary: | summary |