FDA 510(k) Application Details - K202621

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K202621
Device Name	Index-Generating Electroencephalograph Software
Applicant	NeuroWave Systems Inc. 2490 Lee Blvd, Ste 300 Cleveland Heights, OH 44118 US Other 510(k) Applications for this Company
Contact	Tatjana Zikov 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	09/10/2020
Decision Date	08/05/2021
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