510(k) K161063 ยท EHD Unit, X-Ray, Extraoral With Timer
EzRay Air (Model VEX-P300)
| Applicant | VATECH Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Sep 1, 2016 |
| Received | Apr 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161063
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.