K203131 is an FDA 510(k) clearance for the EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 22, 2021, 95 days after receiving the submission on October 19, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K203131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2020 |
| Decision Date | January 22, 2021 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |