510(k) K161865 ยท NDC Calculator, Drug Dose
iSage Rx (iSage Rx Basal Insulin Titration)
| Applicant | Isag Rx, Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Mar 7, 2017 |
| Received | Jul 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161865
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.