510(k) K050091 ยท LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Jan 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050091
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.