FDA 510(k) Application Details - K031374

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K031374
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. HSIN CHU CITY 300 TW Other 510(k) Applications for this Company
Contact	DR. JEN KE MIN 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	04/30/2003
Decision Date	11/28/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review