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FDA 510(k)

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

K-Number: K230022 · 2023-03-31

ApplicantBaxter Healthcare Corporation
Decision Date2023-03-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2023-03-31 under approval number K230022. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library?

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K230022.

When was Baxter SIGMA Spectrum Infusion Pump with Master Drug Library approved by the FDA?

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library received FDA 510(k) clearance on 2023-03-31, under approval number K230022.

What company makes Baxter SIGMA Spectrum Infusion Pump with Master Drug Library?

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Baxter SIGMA Spectrum Infusion Pump with Master Drug Library?

The FDA product code for Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is FRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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