FDA 510(k) K211291, Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, by Fiagon GmbH
FDA 510(k) K211291, Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, by Fiagon GmbH
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number: K211291
Device Name: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Applicant: Fiagon GmbH
Regulation Number: 882.4560
Classification Product Code: PGW
Date Received: 04/28/2021
Decision Date: 07/19/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Ear Nose & Throat
Total number of pages: 1,658
Fully redacted pages: 1,415
Content pages: 243
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