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FDA 510(k)

Quantum Blood and Fluid Warming System

K-Number: K192325 · 2019-10-18

ApplicantLife Warmer, Inc.
Decision Date2019-10-18
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Quantum Blood and Fluid Warming System is a medical device manufactured by Life Warmer, Inc.. It received FDA 510(k) clearance on 2019-10-18 under approval number K192325. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Blood and Fluid Warming System?

Quantum Blood and Fluid Warming System is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Life Warmer, Inc.. The 510(k) number is K192325.

When was Quantum Blood and Fluid Warming System approved by the FDA?

Quantum Blood and Fluid Warming System received FDA 510(k) clearance on 2019-10-18, under approval number K192325.

What company makes Quantum Blood and Fluid Warming System?

Quantum Blood and Fluid Warming System is manufactured by Life Warmer, Inc..

What is the FDA product code for Quantum Blood and Fluid Warming System?

The FDA product code for Quantum Blood and Fluid Warming System is LGZ.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Life Warmer, Inc.

K181775Quantum Blood and IV Fluid Infusion Warmer

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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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