FDA 510(k) Application Details - K093825

Device Classification Name	Electrode, Needle, Diagnostic Electromyograph   More FDA Info for this Device
510(K) Number	K093825
Device Name	Electrode, Needle, Diagnostic Electromyograph
Applicant	AMBU A/S 6740 BAYMEADOW DR. GLEN BURNIE, MD 21060 US Other 510(k) Applications for this Company
Contact	SANJAY PARIKH Other 510(k) Applications for this Contact
Regulation Number	890.1385   More FDA Info for this Regulation Number
Classification Product Code	IKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2009
Decision Date	01/13/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review