FDA 510(k) Application Details - K161282

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K161282
Device Name	Electrode, Cutaneous
Applicant	MEDICO ELECTRODES INTERNATIONAL LTD. PLOT 142A/AA, 12, 27, 28 & 29, NOIDA SPECIAL ECONOMIC ZONE NOIDA 201305 IN Other 510(k) Applications for this Company
Contact	AMIT SETH 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	05/06/2016
Decision Date	10/30/2016
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