510(k) K183332 · JAQ System, Applicator, Radionuclide, Remote-Controlled
BRAXX Esophageal Brachytherapy Applicator
| Applicant | Braxx Biotech Co., Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Apr 16, 2019 |
| Received | Dec 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183332
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.