FDA 510(k) Application Details - K202334

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K202334
Device Name	Electroencephalograph
Applicant	Bioserenity SAS ICM-iPEPS, 47 Boulevard de l'Hopital Paris 75013 FR Other 510(k) Applications for this Company
Contact	Julien Dupont 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	08/17/2020
Decision Date	12/10/2020
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