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FDA 510(k)

QiF Blood and Fluid Warmer

K-Number: K171215 · 2017-09-27

ApplicantQuality IN Flow , Ltd.
Decision Date2017-09-27
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QiF Blood and Fluid Warmer is a medical device manufactured by Quality IN Flow , Ltd.. It received FDA 510(k) clearance on 2017-09-27 under approval number K171215. 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 QiF Blood and Fluid Warmer?

QiF Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2017-09-27. It is manufactured by Quality IN Flow , Ltd.. The 510(k) number is K171215.

When was QiF Blood and Fluid Warmer approved by the FDA?

QiF Blood and Fluid Warmer received FDA 510(k) clearance on 2017-09-27, under approval number K171215.

What company makes QiF Blood and Fluid Warmer?

QiF Blood and Fluid Warmer is manufactured by Quality IN Flow , Ltd..

What is the FDA product code for QiF Blood and Fluid Warmer?

The FDA product code for QiF Blood and Fluid Warmer is LGZ.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07610642 Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers NOT_YET_RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING

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)

Other Devices by Quality IN Flow , Ltd.

K150404QiF Blood and Fluid Warmer K163708QiF Blood and Fluid Warmer K180154QiF Blood and Fluid Warmer K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Related Devices (Code: LGZ)

K161613Hang&Go PACRand S.R.L. K150404QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K163708QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K180154QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc. K180842MAC Medical D-Series Blanket and Solution Warming CabinetsMac 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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