The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Mag Vita Tms Therapy System W/theta Burst Stimulation.
| Device ID | K173620 |
| 510k Number | K173620 |
| Device Name: | Mag Vita TMS Therapy System W/Theta Burst Stimulation |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Tonica Elektronik A/S Lucernemarken 15 Farum, DK 3520 |
| Contact | Sanne Barsballe Jessen |
| Correspondent | Sanne Barsballe Jessen Tonica Elektronik A/S Lucernemarken 15 Farum, DK 3520 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-22 |
| Decision Date | 2018-08-14 |
| Summary: | summary |