FDA 510(k)

EpiAccess System

Número K: K170831 · 2017-05-09

Data da decisão2017-05-09

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EpiAccess System is the device name listed in this FDA 510(k) record. The listed applicant is Epiep, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K170831. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EpiAccess System?

EpiAccess System is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Epiep, Inc.. The 510(k) number is K170831.

When did EpiAccess System receive FDA 510(k) clearance?

EpiAccess System received FDA 510(k) clearance on 2017-05-09, under 510(k) number K170831.

Who is the listed applicant for EpiAccess System?

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

What is the FDA product code for EpiAccess System?

The FDA product code for EpiAccess System is DYB.

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