510(k) K254108— Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

Substantially Equivalent

GN Hearing A/S

Clearance details

Applicant: GN Hearing A/S
Product code: Code QUH
Advisory panel: Ear, Nose, Throat
Date received: 2025-12-19
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, 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.