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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 the device name listed in this FDA 510(k) record. The listed applicant is Life Warmer, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) 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. The listed applicant is Life Warmer, Inc.. The 510(k) number is K192325.

When did Quantum Blood and Fluid Warming System receive FDA 510(k) clearance?

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

Who is the listed applicant for Quantum Blood and Fluid Warming System?

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 Fluid Warming System?

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

K181775Quantum Blood and IV Fluid Infusion 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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