510(k) K173084 ยท FRN Pump, Infusion
Spectrum IQ Infusion System, Dose IQ Safety Software
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, May 11, 2018 |
| Received | Sep 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2022 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion Pumps, Product code 3570009. Open, Classified |
FRN | None listed |
| Aug 11, 2021 | Baxter Healthcare Corporation Dose IQ Safety Software used with Spectrum IQ Infusion Pump Terminated |
FRN | None listed |
| Aug 6, 2021 | Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Terminated |
FRN | None listed |
| Mar 19, 2021 | Baxter Healthcare Corporation Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. Terminated |
FRN | None listed |
| Jan 6, 2021 | Baxter Healthcare Corporation Infusion Pump Terminated |
FRN | None listed |
| Nov 23, 2020 | Baxter Healthcare Corporation Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids. Open, Classified |
FRN | None listed |
| Oct 22, 2020 | Baxter Healthcare Corporation Spectrum IQ Infusion System with Dose IQ Safety Software Terminated |
FRN | None listed |
| Sep 18, 2018 | Baxter Healthcare Corporation SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 Terminated |
PHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.