FDA 510(k) Application Details - K213273

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K213273
Device Name	Index-Generating Electroencephalograph Software
Applicant	Cortical Dynamics Ltd 14 View Street North Perth 6006 AU Other 510(k) Applications for this Company
Contact	Louis Delacretaz Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	09/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review