FDA 510(k) Application Details - K190703

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K190703
Device Name	Stimulator, Electrical, Evoked Response
Applicant	Neurosoft Ltd 5, Voronin str. Ivanovo 153032 RU Other 510(k) Applications for this Company
Contact	Eugene Polezhaev Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2019
Decision Date	05/22/2021
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