Cleared Special

Novum IQ Syringe Pump (40800BAXUS)

K242390 · Baxter Healthcare Corporation · General Hospital
Sep 2024
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K242390 is an FDA 510(k) clearance for the Novum IQ Syringe Pump (40800BAXUS), a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on September 5, 2024, 24 days after receiving the submission on August 12, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K242390 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2024
Decision Date September 05, 2024
Days to Decision 24 days
Submission Type Special
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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