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FDA 510(k)

Quantum Blood and IV Fluid Infusion Warmer

K-Number: K181775 · 2019-01-28

ApplicantLife Warmer, Inc.
Decision Date2019-01-28
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Quantum Blood and IV Fluid Infusion Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Life Warmer, Inc.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K181775. 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 IV Fluid Infusion Warmer?

Quantum Blood and IV Fluid Infusion Warmer is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Life Warmer, Inc.. The 510(k) number is K181775.

When did Quantum Blood and IV Fluid Infusion Warmer receive FDA 510(k) clearance?

Quantum Blood and IV Fluid Infusion Warmer received FDA 510(k) clearance on 2019-01-28, under 510(k) number K181775.

Who is the listed applicant for Quantum Blood and IV Fluid Infusion Warmer?

The FDA 510(k) record lists Life Warmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Blood and IV Fluid Infusion Warmer?

The FDA product code for Quantum Blood and IV Fluid Infusion Warmer is LGZ.

Other records listing Life Warmer, Inc. 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.

K192325Quantum Blood and Fluid Warming System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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