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FDA 510(k)

Novum IQ Large Volume Pump

K-Number: K211122 · 2024-03-29

ApplicantBaxter Healthcare Corporation
Decision Date2024-03-29
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Novum IQ Large Volume 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 2024-03-29 under 510(k) number K211122. 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 Large Volume Pump?

Novum IQ Large Volume Pump is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K211122.

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

Novum IQ Large Volume Pump received FDA 510(k) clearance on 2024-03-29, under 510(k) number K211122.

Who is the listed applicant for Novum IQ Large Volume 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 Large Volume Pump?

The FDA product code for Novum IQ Large Volume 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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