FDA 510(k) Application Details - K001897

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K001897
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. CARRUM DOWNS, VICTORIA 3201 AU Other 510(k) Applications for this Company
Contact	ROB HOPKINS 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	06/21/2000
Decision Date	06/12/2001
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