The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ev1000 Clinical Platform.
| Device ID | K131892 |
| 510k Number | K131892 |
| Device Name: | EV1000 CLINICAL PLATFORM |
| 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 | 2013-06-25 |
| Decision Date | 2014-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103191196 | K131892 | 000 |
| 00690103190113 | K131892 | 000 |
| 00690103190137 | K131892 | 000 |
| 00690103190144 | K131892 | 000 |
| 00690103190151 | K131892 | 000 |
| 00690103190342 | K131892 | 000 |
| 00690103190366 | K131892 | 000 |
| 00690103190731 | K131892 | 000 |
| 00690103190915 | K131892 | 000 |
| 00690103191172 | K131892 | 000 |
| 00690103190106 | K131892 | 000 |