FDA 510(k) Application Details - K982961

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K982961
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	MEDIPOINT LTD. 305 MADISON AVENUE, SUITE 2501 NEW YORK, NY 10165 US Other 510(k) Applications for this Company
Contact	JULES T MITCHEL 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	08/24/1998
Decision Date	06/07/1999
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