Oakville, CA · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | Class II | Neurology | 1 | 2024-11-19 |
| GWJ | Stimulator, Auditory, Evoked Response | Class II | Neurology | 1 | 2024-03-08 |
| HKI | Camera, Ophthalmic, Ac-Powered | Class II | Ophthalmic | 1 | 2021-04-13 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | Class II | Neurology | 1 | 2020-05-18 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-11-19 | K242930 | Natus BrainWatch System | OMC | Class II | Neurology |
| 2024-03-08 | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | GWJ | Class II | Neurology |
| 2021-04-13 | K203500 | RetCam Envision | HKI | Class II | Ophthalmic |
| 2020-05-18 | K200878 | Natus NeuroWorks | OMB | Class II | Neurology |