The following data is part of a premarket notification filed by Nexstim Oy with the FDA for Nexstim Navigated Brain Stimulation (nbs) System 4, Nexstim Nbs System 4 With Nexspeech(tm).
| Device ID | K112881 |
| 510k Number | K112881 |
| Device Name: | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEXSTIM OY ELIMAENKATU 9 B Helsinki, FI Fi-00510 |
| Contact | Rainer Harjunpaa |
| Correspondent | Rainer Harjunpaa NEXSTIM OY ELIMAENKATU 9 B Helsinki, FI Fi-00510 |
| Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430063200125 | K112881 | 000 |
| 06430063200118 | K112881 | 000 |
| 06430063200095 | K112881 | 000 |
| 06430063200088 | K112881 | 000 |
| 06430063200064 | K112881 | 000 |
| 06430063200057 | K112881 | 000 |
| 06430063200033 | K112881 | 000 |
| 06430063200026 | K112881 | 000 |
| 06430063200002 | K112881 | 000 |