FDA 510(k) Application Details - K211291

Device Classification Name	More FDA Info for this Device
510(K) Number	K211291
Device Name	Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Applicant	Fiagon GmbH Neuendorfstr. 23b Hennigsdorf 16761 DE Other 510(k) Applications for this Company
Contact	Dirk Mucha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2021
Decision Date	07/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review