Cleared Traditional

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

K230022 · Baxter Healthcare Corporation · General Hospital
Mar 2023
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K230022 is an FDA 510(k) clearance for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, 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, 86 days after receiving the submission on January 4, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K230022 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2023
Decision Date March 31, 2023
Days to Decision 86 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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