The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ev1000 Clinical Platform With Clearsight Tm Finger Cuff Or Clearsight Tm System.
| Device ID | K140312 |
| 510k Number | K140312 |
| Device Name: | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren 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 | 2014-02-07 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103193879 | K140312 | 000 |
| 00690103193343 | K140312 | 000 |
| 00690103193350 | K140312 | 000 |
| 00690103193367 | K140312 | 000 |
| 00690103193374 | K140312 | 000 |
| 00690103193473 | K140312 | 000 |
| 00690103193480 | K140312 | 000 |
| 00690103193497 | K140312 | 000 |
| 00690103193541 | K140312 | 000 |
| 00690103193558 | K140312 | 000 |
| 00690103193565 | K140312 | 000 |
| 00690103193602 | K140312 | 000 |
| 00690103193619 | K140312 | 000 |
| 00690103193626 | K140312 | 000 |
| 00690103193213 | K140312 | 000 |