510(k) K190256 ยท GXI Probe, Radiofrequency Lesion
Rulo Radiofrequency Lesion Probe
| Applicant | Epimed International, Inc., Farmers Branch TX, US |
| Decision | Substantially Equivalent, Mar 8, 2019 |
| Received | Feb 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190256
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.