The following data is part of a premarket notification filed by Nexstim Oy with the FDA for Nexstim Eximia Navigated Brain Stimulation System.
| Device ID | K091457 |
| 510k Number | K091457 |
| Device Name: | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEXSTIM OY 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte NEXSTIM OY 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-12-08 |