FDA 510(k) Application Details - K190700

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K190700
Device Name	Electrode, Cutaneous
Applicant	Shenzhen Bestpad Technology Development Co., Ltd A16A17 Dong Jing Run Factory A301, Fourth Industrial Zone Shenzhen 518105 CN Other 510(k) Applications for this Company
Contact	Junwei Xu 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	03/18/2019
Decision Date	06/14/2019
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