OneRF Ablation System— 510(k) K231675
Substantially EquivalentNeuroone Medical Technologies Corp.
FDA 510(k) clearance K231675 for OneRF Ablation System, Substantially Equivalent on 2023-12-06. Applicant: Neuroone Medical Technologies Corp..
Clearance details
- Applicant
- Neuroone Medical Technologies Corp.
- Product code
- Code GXD
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Adverse events under product code GXD
product code GXD- Injury
- 228
- Total
- 228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.