The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Magvita Tms Therapy - W/magpro R20.
| Device ID | K170114 |
| 510k Number | K170114 |
| Device Name: | MagVita TMS Therapy - W/MagPro R20 |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK Dk-3520 |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 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 | 2017-01-12 |
| Decision Date | 2017-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713484030290 | K170114 | 000 |
| 05713484030979 | K170114 | 000 |