510(k) K200061 ยท NEY System, Ablation, Microwave And Accessories
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
| Applicant | Galil Medical, Inc., Arden Hills MN, US |
| Decision | Substantially Equivalent, Jul 9, 2020 |
| Received | Jan 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200061
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.