K260189
- 510(k) number
- K260189
- Device name
- MagVenture Accelerated TMS (aTMS) Therapy System
- Applicant
- Tonica Elektronik A/S DK
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2026-05-22
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K260189.pdf
Official FDA record: K260189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.