510(k) K183153 ยท NEY System, Ablation, Microwave And Accessories
Microwave Ablation System
| Applicant | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., Cixi, CN |
| Decision | Substantially Equivalent, Jul 8, 2019 |
| Received | Nov 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183153
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.