FDA 510(k) Application Details - K100116

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K100116
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	LASER HEALTH TECHNOLOGIES, LLC 5600 WISCONSIN AVENUE #509 CHEVY CHASE, MD 20815 US Other 510(k) Applications for this Company
Contact	PATSY J TRISLER Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2010
Decision Date	04/15/2010
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