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FDA 510(k)

SIGMA Spectrum Infusion Pump with Master Drug Library

K-Number: K251640 · 2025-07-28

ApplicantBaxter Healthcare Corporation
Decision Date2025-07-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIGMA Spectrum Infusion Pump with Master Drug Library is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-07-28 under approval number K251640. 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 SIGMA Spectrum Infusion Pump with Master Drug Library?

SIGMA Spectrum Infusion Pump with Master Drug Library is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K251640.

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

SIGMA Spectrum Infusion Pump with Master Drug Library received FDA 510(k) clearance on 2025-07-28, under approval number K251640.

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

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

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

The FDA product code for 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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