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

Ear, Nose, And Throat Stereotaxic Instrument

Fiagon GmbH

The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Cube Navigation System, Virtueye V2, Navigation Sensor Nanorest, Navigation Unit Cube 4d.

Pre-market Notification Details

Device IDK211291
510k NumberK211291
Device Name:Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Fiagon GmbH Neuendorfstr. 23b Hennigsdorf,  DE 16761
ContactDirk Mucha
CorrespondentDirk Mucha
Fiagon GmbH Neuendorfstr. 23b Hennigsdorf,  DE 16761
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-28
Decision Date2021-07-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EFIAE0114301 K211291 000
04260759930126 K211291 000

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