510(k) K191079 ยท ELC Scaler, Ultrasonic
Piezon Built-in Kit, Piezon Built-in Kit LED
| Applicant | E.M.S Electro Medical Systems S.A, Nyon, CH |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Apr 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191079
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.