BRAINSCOPE
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008660657 | 3008660657 | BRAINSCOPE | 1 | N | 2027-01-01 | 7648 Standish Place Rockville MD US 20855 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 138017 | 1435488195 | K190815 | BrainScope TBI | PIW | 2019-09-11 |
| 138017 | 1995174143 | K181179 | BrainScope One | PIW | 2018-05-18 |
| 138017 | 1825806576 | K161068 | Ahead 300 | PIW | 2016-09-22 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PIW | 3 | 2019-09-11 |