SONEX HEALTH, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013479847 | 3013479847 | SONEX HEALTH, Inc | 1 | N | 2026-01-01 | 950 Blue Gentian Road Suite 200 Eagan MN US 55121 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 201819 | 1892348720 | K252594 | UltraGuideCTR® image guided soft tissue release system | HRX | 2025-09-29 |
| 201819 | 2050541490 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRX | 1 | 2025-09-29 |