K100709 is an FDA 510(k) clearance for the EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 7, 2010, 270 days after receiving the submission on March 12, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K100709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2010 |
| Decision Date | December 07, 2010 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |