K112881

Substantially Equivalent

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

Applicant: Nexstim OY
Product code: GWF
Advisory panel: Neurology
Date received: 2011-09-30
Decision date: 2012-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.