510(k) K151298 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Gemini XXP-HP
| Applicant | Dornier Medtech America, Kennesaw GA, US |
| Decision | Substantially Equivalent, Jul 30, 2015 |
| Received | May 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151298
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.