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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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2023-03-31 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K230022.

When did Baxter SIGMA Spectrum Infusion Pump with Master Drug Library receive FDA 510(k) clearance?

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

Who is the listed applicant for Baxter SIGMA Spectrum Infusion Pump with Master Drug Library?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Baxter Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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