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FDA 510(k)

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

K-Number: K211800 · 2022-12-08

ApplicantQuality IN Flow , Ltd.
Decision Date2022-12-08
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Quality IN Flow , Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K211800. 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 Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K211800.

When did Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer receive FDA 510(k) clearance?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer received FDA 510(k) clearance on 2022-12-08, under 510(k) number K211800.

Who is the listed applicant for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA 510(k) record lists Quality IN Flow , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is LGZ.

Other records listing Quality IN Flow , Ltd. as applicant

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.

K180154QiF Blood and Fluid WarmerK171215QiF Blood and Fluid WarmerK163708QiF Blood and Fluid WarmerK150404QiF Blood and Fluid Warmer

Related Devices (Code: LGZ)

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.

K260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC

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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