510(k) K201619 ยท NDC Calculator, Drug Dose
EndoTool IV System
| Applicant | Monarch Medical Technologies, LLC, Charlotte NC, US |
| Decision | Substantially Equivalent, Aug 7, 2020 |
| Received | Jun 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201619
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.