FDA 510(k) Application Details - K143198

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K143198
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Synapse Electroceutical Limited 1 Churchill Court, Hortons Way Westerham TN16 1BT GB Other 510(k) Applications for this Company
Contact	JOHN GILDERSLEEVE Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2014
Decision Date	05/27/2015
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