FDA 510(k) Application Details - K083322

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K083322
Device Name	Amplifier, Physiological Signal
Applicant	NEUROMETRIX, INC. 62 FOURTH AVE. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	RAINER MAAS Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2008
Decision Date	05/27/2009
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