FDA 510(k) Application Details - K160115

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K160115
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	OMRON HEALTHCARE, INC. 1925 WEST FIELD COURT LAKE FOREST, IL 60045 US Other 510(k) Applications for this Company
Contact	RENEE Thornborough 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	01/19/2016
Decision Date	06/03/2016
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