FDA 510(k) Application Details - K220056

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K220056
Device Name	Electroencephalograph
Applicant	iMediSync Inc. 3rd FL. 175 Yeoksam-ro, Gangnam-gu Seoul 06247 KR Other 510(k) Applications for this Company
Contact	Seung Wan Kang 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	01/06/2022
Decision Date	08/10/2022
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