BrainScope TBI is an AI-enabled medical device from BrainScope Company, Inc., listed by FDA (510(k), K190815) with a decision date of 2019-09-11. Review panel: Neurology.
| FDA submission number | K190815 |
|---|---|
| Pathway | 510(k) |
| Company | BrainScope Company, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2019-09-11 |
| Decision | Substantially Equivalent |
| Product code | PIW |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Device class | 2 |
| Regulation number | 882.1450 |
| Review time (calendar days) | 166 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.