FDA 510(k)

EPI K Console

Número K: K172994 · 2017-10-26

Data da decisão2017-10-26

Código do produtoHNO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

EPI K Console is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K172994. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EPI K Console?

EPI K Console is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Moria SA. The 510(k) number is K172994.

When did EPI K Console receive FDA 510(k) clearance?

EPI K Console received FDA 510(k) clearance on 2017-10-26, under 510(k) number K172994.

Who is the listed applicant for EPI K Console?

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

What is the FDA product code for EPI K Console?

The FDA product code for EPI K Console is HNO.

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