Denver, CO, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Class II | Neurology | 1 | 2022-05-06 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-12-08 | Class II | Ongoing | Z-1942-2024 | WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Broc… | — | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. |