FDA 510(k)

LifeFlow Rapid Infusion Device (LifeFlow Device)

Número K: K153731 · 2016-08-25

Data da decisão2016-08-25

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

LifeFlow Rapid Infusion Device (LifeFlow Device) is the device name listed in this FDA 510(k) record. The listed applicant is 410 Medical Innovation, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153731. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LifeFlow Rapid Infusion Device (LifeFlow Device)?

LifeFlow Rapid Infusion Device (LifeFlow Device) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is 410 Medical Innovation, LLC. The 510(k) number is K153731.

When did LifeFlow Rapid Infusion Device (LifeFlow Device) receive FDA 510(k) clearance?

LifeFlow Rapid Infusion Device (LifeFlow Device) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153731.

Who is the listed applicant for LifeFlow Rapid Infusion Device (LifeFlow Device)?

The FDA 510(k) record lists 410 Medical Innovation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device)?

The FDA product code for LifeFlow Rapid Infusion Device (LifeFlow Device) is FPA.

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