510(k) K243032 ยท FFK Lithotriptor, Electro-Hydraulic
EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
| Applicant | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Mar 21, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243032
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.