Racz Neurostat RF Generator— 510(k) K232632
Substantially EquivalentEpimed International
FDA 510(k) clearance K232632 for Racz Neurostat RF Generator, Substantially Equivalent on 2024-05-24. Applicant: Epimed International.
Clearance details
- Applicant
- Epimed International
- Product code
- Code GXD
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Johnstown, NY, 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.