FDA 510(k) Application Details - K181116

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K181116
Device Name	Endoscope, Neurological
Applicant	Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena 07745 DE Other 510(k) Applications for this Company
Contact	Christian Muenster Other 510(k) Applications for this Contact
Regulation Number	882.1480   More FDA Info for this Regulation Number
Classification Product Code	GWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2018
Decision Date	10/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review