The following data is part of a premarket notification filed by Finapres Medical Systems Bv with the FDA for Finapres Nova Noninvasive Hemodynamic Monitor.
| Device ID | K160967 |
| 510k Number | K160967 |
| Device Name: | Finapres Nova Noninvasive Hemodynamic Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FINAPRES MEDICAL SYSTEMS BV HOGEHILWEG 8 Amsterdam, NL 1101 Cc |
| Contact | Ir. Iris Van Uitert |
| Correspondent | Ir. Iris Van Uitert FINAPRES MEDICAL SYSTEMS BV Institutenweg 25, 7521 PH Enschede, NL |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-06 |
| Decision Date | 2017-04-18 |
| Summary: | summary |