K243150
- 510(k) number
- K243150
- Device name
- Nuance Audio Hearing Aid Software
- Applicant
- Luxottica Group S.P.A. IT
- Product code
- SCR — Air-Conduction Hearing Aid Software
- Decision date
- 2025-01-31
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243150.pdf
Official FDA record: K243150
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.