510(k) K212788 ยท GWQ Full-Montage Standard Electroencephalograph
Seer Home
| Applicant | Seer Medical Pty, Ltd., Melbourne, AU |
| Decision | Substantially Equivalent, Jun 16, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2024 | SEER MEDICAL PTY LTD Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Mon Open, Classified |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.