The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Ev1000 Clinical Platform.
| Device ID | K193179 |
| 510k Number | K193179 |
| Device Name: | EV1000 Clinical Platform |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Jamie Byun |
| Correspondent | Jamie Byun 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 | 2019-11-18 |
| Decision Date | 2019-12-17 |