Braincare USA Corp.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023074935 | 3023074935 | Braincare USA Corp. | 1 | Y | 2026-01-01 | 6470 E Johns Crossing Suite 160 Office 114 Johns Creek GA US 30097 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 317193 | 1445177650 | K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | GWM | 2024-07-18 |
| 317193 | 1090548364 | K201989 | B4C System | GWM | 2021-10-08 |
| 317193 | 1863986601 | K182073 | BcSs-PICNI-2000 Sensor | GWM | 2019-10-17 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GWM | 3 | 2024-07-18 |