FDA 510(k)

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D

N.º K: K211291 · 2021-07-19

Fecha de decisión2021-07-19

Código de productoPGW

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K211291. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is Fiagon GmbH. The 510(k) number is K211291.

When did Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D receive FDA 510(k) clearance?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D received FDA 510(k) clearance on 2021-07-19, under 510(k) number K211291.

Who is the listed applicant for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

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

What is the FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

The FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is PGW.

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Otros registros que enlistan a Fiagon GmbH como solicitante

K261540Cube 4D Navigation System, VirtuEye Pro K230700RIWOtrack Navigation System K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System K201472VenSure Balloon Device, VenSure Nav Balloon Device K200041FlexPointer 1.5 Single Use, FlexTube 3 Single Use K163209Fiagon Navigation System

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Fuente oficial

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