510(k) K180561 ยท EHD Unit, X-Ray, Extraoral With Timer
MobileX Portable X-ray System
| Applicant | Denterprise International, Inc., Ormond Beach FL, US |
| Decision | Substantially Equivalent, Apr 4, 2018 |
| Received | Mar 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180561
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.