K230853
- 510(k) number
- K230853
- Device name
- EARP Nerve Cuff Electrode
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- ETN — Stimulator, Nerve
- Decision date
- 2023-10-06
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230853.pdf
Official FDA record: K230853
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.