510(k) K221963 ยท GWQ Full-Montage Standard Electroencephalograph
Cumulus Functional Neurophysiology Platform
| Applicant | Cumulus Neuroscience Limited, Belfast, IE |
| Decision | Substantially Equivalent, Apr 27, 2023 |
| Received | Jul 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221963
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.