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FDA 510(k)

Dose IQ Safety Software

K-Number: K211124 · 2022-08-30

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

Device Summary

Dose IQ Safety Software 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 K211124. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dose IQ Safety Software?

Dose IQ Safety Software 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 K211124.

When did Dose IQ Safety Software receive FDA 510(k) clearance?

Dose IQ Safety Software received FDA 510(k) clearance on 2022-08-30, under 510(k) number K211124.

Who is the listed applicant for Dose IQ Safety Software?

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 Dose IQ Safety Software?

The FDA product code for Dose IQ Safety Software is PHC.

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Related Devices (Code: PHC)

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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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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