The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Ev1000 Clinical Platform With Clearsight Finger Cuff Or Clearsight System, Ev1000 Clinical Platform.
| Device ID | K160552 |
| 510k Number | K160552 |
| Device Name: | EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | EDWARDS LIFESCIENCES, LLC ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani EDWARDS LIFESCIENCES, LLC ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103190892 | K160552 | 000 |
| 00690103190243 | K160552 | 000 |
| 00690103190236 | K160552 | 000 |
| 00690103190229 | K160552 | 000 |