510(k) K181888 ยท EKX Handpiece, Direct Drive, Ac-Powered
Osstell Beacon
| Applicant | Osstell AB, Gotenborg, SE |
| Decision | Substantially Equivalent, Aug 22, 2019 |
| Received | Jul 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181888
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.