K243869
- 510(k) number
- K243869
- Device name
- Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
- Applicant
- The Magstim Company Limited GB
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-03-17
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243869.pdf
Official FDA record: K243869
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.