FDA 510(k) Application Details - K221963

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K221963
Device Name	Electroencephalograph
Applicant	Cumulus Neuroscience Limited The Innovation Center, Unit 4, Queens Road Belfast BT3 9DT IE Other 510(k) Applications for this Company
Contact	Caroline Kirwan Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2022
Decision Date	04/27/2023
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