510(k) K211452 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Encevis
| Applicant | Austrian Institute of Technology GmbH, Vienna, AT |
| Decision | Substantially Equivalent, Dec 2, 2021 |
| Received | May 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211452
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.