510(k) K233464— WSA Self-Fitting Hearing Aid Gen 2

Substantially Equivalent

Wsaud A/S

Clearance details

Applicant: Wsaud A/S
Product code: Code QUH
Advisory panel: Ear, Nose, Throat
Date received: 2023-10-23
Decision date: 2024-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Lynge, DK

Adverse events under product code QUH

product code QUH

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.