510(k) K192867 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
| Applicant | Bovie Medical Corporation Dba Apyx Medical Corporation, Clearwater FL, US |
| Decision | Substantially Equivalent, Oct 31, 2019 |
| Received | Oct 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192867
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.