FDA 510(k)

CardioFlux with Faraday Analytical Cloud

Número K: K182571 · 2019-03-15

Data da decisão2019-03-15

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CardioFlux with Faraday Analytical Cloud is the device name listed in this FDA 510(k) record. The listed applicant is Genetesis, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182571. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CardioFlux with Faraday Analytical Cloud?

CardioFlux with Faraday Analytical Cloud is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Genetesis, Inc.. The 510(k) number is K182571.

When did CardioFlux with Faraday Analytical Cloud receive FDA 510(k) clearance?

CardioFlux with Faraday Analytical Cloud received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182571.

Who is the listed applicant for CardioFlux with Faraday Analytical Cloud?

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

What is the FDA product code for CardioFlux with Faraday Analytical Cloud?

The FDA product code for CardioFlux with Faraday Analytical Cloud is DPS.

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