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FDA 510(k)

Novum IQ Syringe Pump

K-Number: K211125 · 2022-08-30

ApplicantBaxter Healthcare Corporation
Decision Date2022-08-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Novum IQ Syringe Pump 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 2022-08-30 under 510(k) number K211125. 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 Novum IQ Syringe Pump?

Novum IQ Syringe Pump is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K211125.

When did Novum IQ Syringe Pump receive FDA 510(k) clearance?

Novum IQ Syringe Pump received FDA 510(k) clearance on 2022-08-30, under 510(k) number K211125.

Who is the listed applicant for Novum IQ Syringe Pump?

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 Novum IQ Syringe Pump?

The FDA product code for Novum IQ Syringe Pump 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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