Cleared Traditional

Spectrum IQ Infusion System with Dose IQ Safety Software

K230041 · Baxter Healthcare Corporation · General Hospital
Mar 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K230041 is an FDA 510(k) clearance for the Spectrum IQ Infusion System with Dose IQ Safety Software, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on March 31, 2023, 84 days after receiving the submission on January 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K230041 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2023
Decision Date March 31, 2023
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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