The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ev1000 Platform Model: Ev1000a, Ev1000db, Ev1000m.
| Device ID | K100709 |
| 510k Number | K100709 |
| Device Name: | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Patricia Milbank, Jd |
| Correspondent | Patricia Milbank, Jd 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 | 2010-03-12 |
| Decision Date | 2010-12-07 |
| Summary: | summary |