510(k) K142358 ยท EKX Handpiece, Direct Drive, Ac-Powered
Osstell IDx
| Applicant | Osstell AB, Gothenburg, SE |
| Decision | Substantially Equivalent, Feb 19, 2015 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142358
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.