K251119
- 510(k) number
- K251119
- Device name
- MagVenture TMS Therapy System
- Applicant
- Tonica Elektronik A/S DK
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-08-08
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251119.pdf
Official FDA record: K251119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.