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 | K150641 |
| 510k Number | K150641 |
| Device Name: | MagVita TMS Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 3520 |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen 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 | 2015-03-11 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713484031068 | K150641 | 000 |
| 05713484030955 | K150641 | 000 |
| 05713484031051 | K150641 | 000 |
| 05713484031105 | K150641 | 000 |
| 05713484030078 | K150641 | 000 |
| 05713484030306 | K150641 | 000 |
| 05713484030313 | K150641 | 000 |
| 05713484030337 | K150641 | 000 |
| 05713484030405 | K150641 | 000 |
| 05713484031211 | K150641 | 000 |
| 05713484030054 | K150641 | 000 |
| 05713484030160 | K150641 | 000 |
| 05713484030924 | K150641 | 000 |
| 05713484030283 | K150641 | 000 |