K252032
- 510(k) number
- K252032
- Device name
- T65 (9016E061-)
- Applicant
- Tonica Elektronik A/S DK
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-07-30
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252032.pdf
Official FDA record: K252032
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.