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FDA 510(k)

QiF Blood and Fluid Warmer

K-Number: K163708 · 2017-04-20

ApplicantQuality IN Flow , Ltd.
Decision Date2017-04-20
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QiF 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 2017-04-20 under 510(k) number K163708. 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 2017-04-20. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K163708.

When did QiF Blood and Fluid Warmer receive FDA 510(k) clearance?

QiF Blood and Fluid Warmer received FDA 510(k) clearance on 2017-04-20, under 510(k) number K163708.

Who is the listed applicant for QiF 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 QiF Blood and Fluid Warmer?

The FDA product code for QiF 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.

K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerK180154QiF Blood and Fluid WarmerK171215QiF 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.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

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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