FDA 510(k)

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

K-Nummer: K251636 · 2025-07-28

AntragstellerBaxter Healthcare Corporation

Entscheidungsdatum2025-07-28

ProduktcodeFRN

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) 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 2025-07-28 under 510(k) number K251636. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K251636.

When did Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) receive FDA 510(k) clearance?

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251636.

Who is the listed applicant for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

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 Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)?

The FDA product code for Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) is FRN.

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Offizielle Quelle

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