510(k) K172928 ยท EHD Unit, X-Ray, Extraoral With Timer
Portable X-ray System
| Applicant | Rolence Enterprise, Inc., Taoyuan, TW |
| Decision | Substantially Equivalent, Mar 16, 2018 |
| Received | Sep 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172928
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.