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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 a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-08-30 under approval 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. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K211124.

When was Dose IQ Safety Software approved by the FDA?

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

What company makes Dose IQ Safety Software?

Dose IQ Safety Software is manufactured by Baxter Healthcare Corporation.

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 PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

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Related Devices (Code: PHC)

K182092BD Intelliport SystemBecton, Dickinson and Company K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG K223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc. K230665Dose IQ Safety SoftwareBaxter Healthcare Corporation K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)Becton Dickinson K242117LifeShield Infusion Safety Software SuiteIcu Medical, 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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