510(k) K123038 ยท FFK Lithotriptor, Electro-Hydraulic
SWISS LITHOBREAKER
| Applicant | E.M.S Electro Medical Systems S.A, Southbrough MA, US |
| Decision | Substantially Equivalent, Jan 16, 2013 |
| Received | Sep 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123038
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.