FDA 510(k)

Alleye

Número K: K180895 · 2018-06-27

Data da decisão2018-06-27

Código do produtoHOQ

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alleye is the device name listed in this FDA 510(k) record. The listed applicant is Oculocare Medical AG. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180895. The device is classified under product code HOQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Alleye?

Alleye is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Oculocare Medical AG. The 510(k) number is K180895.

When did Alleye receive FDA 510(k) clearance?

Alleye received FDA 510(k) clearance on 2018-06-27, under 510(k) number K180895.

Who is the listed applicant for Alleye?

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

What is the FDA product code for Alleye?

The FDA product code for Alleye is HOQ.

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