The following data is part of a premarket notification filed by Edwards Lifesciences with the FDA for Ev1000 Clinical Platform.
| Device ID | K110597 |
| 510k Number | K110597 |
| Device Name: | EV1000 CLINICAL PLATFORM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson EDWARDS LIFESCIENCES 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 | 2011-03-02 |
| Decision Date | 2011-06-14 |
| Summary: | summary |