The following data is part of a premarket notification filed by Nexstim Plc with the FDA for Nexstim Navigated Brain Therapy (nbt) System 2.
| Device ID | K182700 |
| 510k Number | K182700 |
| Device Name: | Nexstim Navigated Brain Therapy (NBT) System 2 |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Nexstim Plc Elimaenkatu 9b Helsinki, FI 00510 |
| Contact | Anna Honkanen |
| Correspondent | Anna Honkanen Nexstim Plc Elimaenkatu 9b Helsinki, FI 00510 |
| Product Code | OBP |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HAW |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-03-22 |
| Summary: | summary |