FDA 510(k)

Sistema de Imágenes ApolloVue S100

N.º K: K201552 · 2020-09-02

Fecha de decisión2020-09-02

Código de productoNQQ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ApolloVue S100 Image System is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Medical Optics, Ltd.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K201552. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ApolloVue S100 Image System?

ApolloVue S100 Image System is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Apollo Medical Optics, Ltd.. The 510(k) number is K201552.

When did ApolloVue S100 Image System receive FDA 510(k) clearance?

ApolloVue S100 Image System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201552.

Who is the listed applicant for ApolloVue S100 Image System?

The FDA 510(k) record lists Apollo Medical Optics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ApolloVue S100 Image System?

The FDA product code for ApolloVue S100 Image System is NQQ.

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Fuente oficial

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