Brainscope Company, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190815 | BrainScope TBI | September 11, 2019 |
| K183241 | BrainScope TBI (Model: Ahead 400) | February 19, 2019 |
| K181785 | Modified BrainScope One | December 19, 2018 |
| K181179 | BrainScope One | May 18, 2018 |
| K161068 | Ahead 300 | September 22, 2016 |
| K143643 | Brainscope Ahead 200 | May 15, 2015 |
| DEN140025 | BrainScope Ahead 100 | November 17, 2014 |
| K082886 | ZOOM-100DC | August 10, 2009 |