MagVenture TMS Atlas Neuro Navigation System— 510(k) K221544

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K221544 for MagVenture TMS Atlas Neuro Navigation System, Substantially Equivalent on 2023-03-17. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant: Tonica Elektronik A/S
Product code: Code HAW
Advisory panel: Neurology
Date received: 2022-05-27
Decision date: 2023-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farum, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.