FDA 510(k) Application Details - K120516

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K120516
Device Name	Electrode, Cutaneous
Applicant	OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	02/21/2012
Decision Date	05/17/2012
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