The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Vigilance Ii Continuous Cardiac Output/oximetry/volumetric Monitor, Model Vig2.
| Device ID | K043103 |
| 510k Number | K043103 |
| Device Name: | VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2004-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103191165 | K043103 | 000 |
| 00690103002782 | K043103 | 000 |
| 00690103002775 | K043103 | 000 |
| 00690103002768 | K043103 | 000 |
| 00690103002737 | K043103 | 000 |
| 00690103002676 | K043103 | 000 |
| 00690103002614 | K043103 | 000 |
| 00690103002508 | K043103 | 000 |
| 00690103002485 | K043103 | 000 |
| 00690103002478 | K043103 | 000 |
| 00690103002461 | K043103 | 000 |
| 00690103002799 | K043103 | 000 |
| 00690103004250 | K043103 | 000 |
| 00690103005271 | K043103 | 000 |
| 00690103186086 | K043103 | 000 |
| 00690103181579 | K043103 | 000 |
| 00690103181562 | K043103 | 000 |
| 00690103181555 | K043103 | 000 |
| 00690103181548 | K043103 | 000 |
| 00690103181500 | K043103 | 000 |
| 00690103181494 | K043103 | 000 |
| 00690103181470 | K043103 | 000 |
| 00690103181463 | K043103 | 000 |
| 00690103008463 | K043103 | 000 |
| 00690103002454 | K043103 | 000 |