510(k) K243743 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
autoSCORE (V 2.0.0)
| Applicant | Holberg Eeg AS, Bergen, NO |
| Decision | Substantially Equivalent, Apr 9, 2025 |
| Received | Dec 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243743
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.