K223911
- 510(k) number
- K223911
- Device name
- Lumen 155-SF
- Applicant
- Intricon Corporation MN · US
- Product code
- QDD — Self-Fitting Air-Conduction Hearing Aid, Prescriptio
- Decision date
- 2023-10-17
- Date received
- 2022-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K223911.pdf
Official FDA record: K223911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.