FDA 510(k) Application Details - K103031

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K103031
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST GALWAY EI IE Other 510(k) Applications for this Company
Contact	ANNE-MARIE KEENAN Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2010
Decision Date	11/10/2011
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