The following data is part of a premarket notification filed by Finapres Medical Systems B.v. with the FDA for Finapres Nova Noninvasive Hemodynamic Monitor.
| Device ID | K173916 |
| 510k Number | K173916 |
| Device Name: | Finapres Nova Noninvasive Hemodynamic Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Finapres Medical Systems B.V. Institutenweg 25 Enschede, NL 7521 Ph |
| Contact | Iris Van Uitert |
| Correspondent | Iris Van Uitert Finapres Medical Systems B.V. Institutenweg 25 Enschede, NL 7521 Ph |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-11-06 |
| Summary: | summary |