FDA 510(k)

Lunoa System

Número K: K180608 · 2018-06-05

Data da decisão2018-06-05

Código do produtoMYB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lunoa System is the device name listed in this FDA 510(k) record. The listed applicant is Nightbalance BV. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K180608. The device is classified under product code MYB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lunoa System?

Lunoa System is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Nightbalance BV. The 510(k) number is K180608.

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

Lunoa System received FDA 510(k) clearance on 2018-06-05, under 510(k) number K180608.

Who is the listed applicant for Lunoa System?

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

What is the FDA product code for Lunoa System?

The FDA product code for Lunoa System is MYB.

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