FDA 510(k)

Fluido Compact Blood and Fluid Warming System

Número K: K211618 · 2023-06-05

RequerenteThe Surgical Company International B.V.

Data da decisão2023-06-05

Código do produtoLGZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fluido Compact Blood and Fluid Warming System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International B.V.. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K211618. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fluido Compact Blood and Fluid Warming System?

Fluido Compact Blood and Fluid Warming System is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is The Surgical Company International B.V.. The 510(k) number is K211618.

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

Fluido Compact Blood and Fluid Warming System received FDA 510(k) clearance on 2023-06-05, under 510(k) number K211618.

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

The FDA 510(k) record lists The Surgical Company International B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluido Compact Blood and Fluid Warming System?

The FDA product code for Fluido Compact Blood and Fluid Warming System is LGZ.

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Outros registros que listam The Surgical Company International B.V. como candidato(a)

K252636Fluido Compact System

Dispositivos Relacionados (Código: LGZ)

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

Fonte oficial

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