K231675
- 510(k) number
- K231675
- Device name
- OneRF Ablation System
- Applicant
- Neuroone Medical Technologies Corp. MN · US
- Product code
- GXD — Generator, Lesion, Radiofrequency
- Decision date
- 2023-12-06
- Date received
- 2023-06-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K231675.pdf
Official FDA record: K231675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.