FDA 510(k) Applications for Medical Device Product Code "PIW"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K161068 | BRAINSCOPE COMPANY INC | Ahead 300 | 09/22/2016 |
| K181179 | BrainScope Company Inc. | BrainScope One | 05/18/2018 |
| K183241 | BrainScope Company Inc. | BrainScope TBI (Model: Ahead 400) | 02/19/2019 |
| K181785 | BrainScope Company Inc. | Modified BrainScope One | 12/19/2018 |
| DEN140025 | BRAINSCOPE COMPANY, INC | BrainScope Ahead 100 | 11/17/2014 |
| K143643 | BRAINSCOPE COMPANY, INC. | Brainscope Ahead 200 | 05/15/2015 |
| K190815 | BrainScope Company, Inc. | BrainScope TBI | 09/11/2019 |
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