510(k) K213897 ยท EKX Handpiece, Direct Drive, Ac-Powered
Pro M Class
| Applicant | Saeyang Microtech Co., Ltd., Daegu, KR |
| Decision | Substantially Equivalent, Sep 19, 2022 |
| Received | Dec 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213897
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.