510(k) K201308— Axonpen, Axonmonitor, Axonbox, Tablet

Substantially Equivalent

Clearmind Biomedical

Clearance details

Applicant: Clearmind Biomedical
Product code: Code GWG
Advisory panel: Neurology
Date received: 2020-05-15
Decision date: 2020-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.