The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Magvita Tms Therapy System.
| Device ID | K171967 |
| 510k Number | K171967 |
| Device Name: | MagVita TMS Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Tonica Elektronik A/S Lucernemarken 15 Farum, DK |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen Tonica Elektronik A/S Lucernemarken 15 Farum, DK |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-07-25 |
| Summary: | summary |