FDA 510(k) Application Details - K200925

Device Classification Name	Endoscope, Neurological   More FDA Info for this Device
510(K) Number	K200925
Device Name	Endoscope, Neurological
Applicant	Clarus Medical, LLC 13355 10th Ave N Suite 110 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Mark F. Brown 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	04/07/2020
Decision Date	03/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review