510(k) K153285 ยท EKX Handpiece, Direct Drive, Ac-Powered
EMS-200
| Applicant | Meta Systems Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Aug 12, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153285
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.