Melbourne, AU · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | Class II | Neurology | 1 | 2022-06-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-08-12 | Class II | Ongoing | Z-3143-2024 | Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video… | — | During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF r… |