FDA 510(k)

Epiphany Cardio Server Mobile

Número K: K181720 · 2018-07-30

Data da decisão2018-07-30

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Epiphany Cardio Server Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Epiphany Healthcare, LLC. It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181720. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Epiphany Cardio Server Mobile?

Epiphany Cardio Server Mobile is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Epiphany Healthcare, LLC. The 510(k) number is K181720.

When did Epiphany Cardio Server Mobile receive FDA 510(k) clearance?

Epiphany Cardio Server Mobile received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181720.

Who is the listed applicant for Epiphany Cardio Server Mobile?

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

What is the FDA product code for Epiphany Cardio Server Mobile?

The FDA product code for Epiphany Cardio Server Mobile is DQK.

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Fonte oficial

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