510(k) K201054 ยท OLV Standard Polysomnograph With Electroencephalograph
SOMNOscreen plus
| Applicant | Somnomedics GmbH, Randersacker, DE |
| Decision | Substantially Equivalent, Aug 12, 2020 |
| Received | Apr 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201054
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.