510(k) K132547 ยท NDC Calculator, Drug Dose
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
| Applicant | Monarch Medical Technologies, Silver Spring MD, US |
| Decision | Substantially Equivalent, Apr 17, 2014 |
| Received | Aug 13, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2019 | Monarch Medical Technologies Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Open, Classified |
NDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.