FDA 510(k) Application Details - K183437

Device Classification Name	Electrode, Cortical   More FDA Info for this Device
510(K) Number	K183437
Device Name	Electrode, Cortical
Applicant	CorTec GmbH Neuer Messplatz 3 Freiburg i. Br. D-79108 DE Other 510(k) Applications for this Company
Contact	Mara Assis Other 510(k) Applications for this Contact
Regulation Number	882.1310   More FDA Info for this Regulation Number
Classification Product Code	GYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2018
Decision Date	03/12/2019
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