BrainScope TBI (Model: Ahead 400)— 510(k) K183241
Substantially EquivalentBrainscope Company, Inc.
FDA 510(k) clearance K183241 for BrainScope TBI (Model: Ahead 400), Substantially Equivalent on 2019-02-19. Applicant: Brainscope Company, Inc..
Clearance details
- Applicant
- Brainscope Company, Inc.
- Product code
- Code PIW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.