The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Ev1000 Clinical Platform Non-invasive (ni) Or Clearsight System, Ev1000 Clinical Platform.
| Device ID | K203131 |
| 510k Number | K203131 |
| Device Name: | EV1000 Clinical Platform Non-Invasive (NI) Or ClearSight System, EV1000 Clinical Platform |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Christine Chun |
| Correspondent | Christine Chun Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DXN |
| Subsequent Product Code | DXG |
| Subsequent Product Code | QAQ |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-19 |
| Decision Date | 2021-01-22 |