510(k) K192889 ยท OMA Amplitude-Integrated Electroencephalograph
Neo
| Applicant | Eemagine Medical Imaging Solutions GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Jan 30, 2020 |
| Received | Oct 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192889
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.