510(k) K093816 ยท KPR System, X-Ray, Stationary
DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
| Applicant | Medien International Co, Ltd., Echo OR, US |
| Decision | Substantially Equivalent, Oct 5, 2010 |
| Received | Dec 11, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093816
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.