The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for The Clearsight Finger Cuffs.
| Device ID | K190130 |
| 510k Number | K190130 |
| Device Name: | The ClearSight Finger Cuffs |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Christine J. Chun |
| Correspondent | Christine J. Chun 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 | 2019-01-28 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103199623 | K190130 | 000 |
| 50690103199616 | K190130 | 000 |
| 50690103199609 | K190130 | 000 |
| 50690103203344 | K190130 | 000 |
| 50690103203337 | K190130 | 000 |
| 50690103203320 | K190130 | 000 |