510(k) K203772 ยท QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Omnipod 5 SmartBolus Calculator
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Jan 27, 2022 |
| Received | Dec 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203772
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.