FDA 510(k)

Nexy

Número K: K180306 · 2018-06-08

Data da decisão2018-06-08

Código do produtoHKI

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nexy is the device name listed in this FDA 510(k) record. The listed applicant is Next Sight Srl. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180306. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nexy?

Nexy is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Next Sight Srl. The 510(k) number is K180306.

When did Nexy receive FDA 510(k) clearance?

Nexy received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180306.

Who is the listed applicant for Nexy?

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

What is the FDA product code for Nexy?

The FDA product code for Nexy is HKI.

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