510(k) K142428 ยท FEO Lithotriptor, Ultrasonic
Shock Pulse-SE Lithotripsy System CYBERWAND II
| Applicant | Cybersonics, Inc., Erie PA, US |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Aug 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2020 | Olympus Corporation of the Americas OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer Terminated |
FEO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.