Spectrum IQ Infusion System with Dose IQ Safety Software

Spectrum IQ Infusion System with Dose IQ Safety Software is an FDA 510(k)-cleared medical device (K230041) manufactured by Baxter Healthcare Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 2023. Regulation: 8.