The following data is part of a premarket notification filed by Bmeye B.v. with the FDA for Nexfin Model 2.
| Device ID | K101123 |
| 510k Number | K101123 |
| Device Name: | NEXFIN MODEL 2 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BMEYE B.V. 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William F Greenrose |
| Correspondent | William F Greenrose BMEYE B.V. 220 RIVER ROAD Claremont, NH 03743 |
| 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 | 2010-04-22 |
| Decision Date | 2010-10-28 |
| Summary: | summary |