The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Nexfin Model 2.
| Device ID | K122381 |
| 510k Number | K122381 |
| Device Name: | NEXFIN MODEL 2 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSB |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2013-04-22 |
| Summary: | summary |