FDA 510(k)

Asimov-MKS Imaging System

N.º K: K192761 · 2020-01-17

Fecha de decisión2020-01-17

Código de productoIZI

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Asimov-MKS Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Onlume, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192761. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Asimov-MKS Imaging System?

Asimov-MKS Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Onlume, Inc.. The 510(k) number is K192761.

When did Asimov-MKS Imaging System receive FDA 510(k) clearance?

Asimov-MKS Imaging System received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192761.

Who is the listed applicant for Asimov-MKS Imaging System?

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

What is the FDA product code for Asimov-MKS Imaging System?

The FDA product code for Asimov-MKS Imaging System is IZI.

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Fuente oficial

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