FDA 510(k) Application Details - K161491

Device Classification Name	More FDA Info for this Device
510(K) Number	K161491
Device Name	Scopis Hybrid Navigation System EM
Applicant	Scopis GmbH Heinrich-Heine-Platz 10 Berlin 10179 DE Other 510(k) Applications for this Company
Contact	Christopher Ozbek 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	06/01/2016
Decision Date	02/09/2017
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