510(k) K221903 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Delta III Pro
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 22, 2023 |
| Received | Jun 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221903
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.