The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Vigileo Arterial Pressure Cardiac Output/oximetry Monitor; Vigileo Apco/oximetry Monitor.
| Device ID | K131588 |
| 510k Number | K131588 |
| Device Name: | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Sally Maher |
| Correspondent | Sally Maher 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 | 2013-05-31 |
| Decision Date | 2014-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103194760 | K131588 | 000 |
| 00690103181418 | K131588 | 000 |
| 00690103181449 | K131588 | 000 |
| 00690103181456 | K131588 | 000 |
| 00690103184976 | K131588 | 000 |
| 00690103186093 | K131588 | 000 |
| 00690103187267 | K131588 | 000 |
| 00690103194586 | K131588 | 000 |
| 00690103194593 | K131588 | 000 |
| 00690103194609 | K131588 | 000 |
| 00690103194616 | K131588 | 000 |
| 00690103194722 | K131588 | 000 |
| 00690103194739 | K131588 | 000 |
| 00690103194746 | K131588 | 000 |
| 00690103194753 | K131588 | 000 |
| 00690103165418 | K131588 | 000 |