FDA 510(k) Application Details - K232159

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K232159
Device Name	Endoscope, Neurological
Applicant	Carl Zeiss Meditec AG Rudolf-Eber-Strasse 11 Oberkochen 73447 DE Other 510(k) Applications for this Company
Contact	Eva Jankovics 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	07/20/2023
Decision Date	09/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review