Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation— 510(k) K211389

Substantially Equivalent

Magstim Company, Ltd.

FDA 510(k) clearance K211389 for Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation, Substantially Equivalent on 2021-09-14. Applicant: Magstim Company, Ltd..

Clearance details

Applicant: Magstim Company, Ltd.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2021-05-05
Decision date: 2021-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitland, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.