510(k) K193232 ยท NEY System, Ablation, Microwave And Accessories
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Feb 13, 2020 |
| Received | Nov 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193232
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.