K243709
- 510(k) number
- K243709
- Device name
- NeuroEars-Anna
- Applicant
- Neuroears, Inc. KR
- Product code
- GWN — Nystagmograph
- Decision date
- 2025-08-25
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243709.pdf
Official FDA record: K243709
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.