FDA 510(k) Application Details - K190115

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K190115
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	MingHuangDa Electronic Co., Ltd Floor6, Building A, Taixinglong Industrial Park Hezhou Village, Xixiang Town Baoan District, Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Zhang Guixiang Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2019
Decision Date	06/19/2019
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