510(k) K222048

Spectrum IQ Infusion System with Dose IQ Safety Software by Baxter Healthcare Corporation — Product Code FRN

K222048 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Spectrum IQ Infusion System with Dose IQ Safety Software". The FDA issued a decision of Substantially Equivalent on September 6, 2022. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.