510(k) K202369 ยท MUH System, X-Ray, Extraoral Source, Digital
RXS 1000
| Applicant | Rolence Enterprise, Inc., Taoyuan, TW |
| Decision | Substantially Equivalent, Sep 15, 2021 |
| Received | Aug 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202369
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.