510(k) K243097 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
RM STAR EX with RMS Needle
| Applicant | Bomtech Electronics Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Dec 26, 2024 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243097
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.