510(k) K162119 ยท FFK Lithotriptor, Electro-Hydraulic
UreTron PF Series Probe
| Applicant | Med-Sonics Corp., Erie PA, US |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | Aug 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162119
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.