CEFALY— 510(k) DEN120019

Unknown

Stx-Med Sprl

FDA 510(k) clearance DEN120019 for CEFALY, Unknown on 2014-03-11. Applicant: Stx-Med Sprl.

Clearance details

Applicant: Stx-Med Sprl
Product code: Code PCC
Advisory panel: Neurology
Date received: 2012-12-13
Decision date: 2014-03-11
Decision: Unknown
Clearance type: Post-NSE
Location: Herstal, Liege, BE

View on FDA.gov ↗

Adverse events under product code PCC

product code PCC

Other: 1
Total: 1

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.