FDA 510(k) Application Details - K083679

Device Classification Name	Electromyograph, Diagnostic   More FDA Info for this Device
510(K) Number	K083679
Device Name	Electromyograph, Diagnostic
Applicant	UROVAL 5353 WAYZATA BLVD. SUITE 505 MINNEAPOLIS, MN 55416 US Other 510(k) Applications for this Company
Contact	SHARON IVERSON Other 510(k) Applications for this Contact
Regulation Number	890.1375   More FDA Info for this Regulation Number
Classification Product Code	IKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2008
Decision Date	09/11/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review