FDA 510(k) Application Details - K973980

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K973980
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET HSI-CHIH CITY, TAIPEI HSIEN TW Other 510(k) Applications for this Company
Contact	DANIEL LEE 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	10/20/1997
Decision Date	07/29/1998
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