The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Magventure Tms Therapy – For Treatment Of Ocd, Magventure Tms Therapy System.
| Device ID | K193006 |
| 510k Number | K193006 |
| Device Name: | MagVenture TMS Therapy – For Treatment Of OCD, MagVenture TMS Therapy System |
| Classification | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| 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 | QCI |
| CFR Regulation Number | 882.5802 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2020-08-09 |