510(k) K192549 ยท OMC Reduced- Montage Standard Electroencephalograph
Byteflies Kit
| Applicant | Byteflies NV, Antwerp, BE |
| Decision | Substantially Equivalent, Jun 22, 2020 |
| Received | Sep 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192549
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.