FDA 510(k) Application Details - K213299

Device Classification Name	Non-Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K213299
Device Name	Non-Normalizing Quantitative Electroencephalograph Software
Applicant	Pascall Systems Inc 200 Portland St Boston, MA 02114 US Other 510(k) Applications for this Company
Contact	Tuan Le Mau Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2021
Decision Date	05/11/2022
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