510(k) K111947 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
DUET MAGNA
| Applicant | Direx Systems Corp., Canton MA, US |
| Decision | Substantially Equivalent, Mar 1, 2012 |
| Received | Jul 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111947
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.