FDA 510(k) Application Details - K211315

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K211315
Device Name	Electrode, Cutaneous
Applicant	Pamel d.o.o Mesekov Put 16 Zagreb 10090 HR Other 510(k) Applications for this Company
Contact	Marko Pavic Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2021
Decision Date	11/09/2021
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