FDA 510(k) Application Details - K091369

Device Classification Name	Analyzer, Body Composition   More FDA Info for this Device
510(K) Number	K091369
Device Name	Analyzer, Body Composition
Applicant	AKERN USA, LLC 5401 S. COTTONWOOD COURT GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	KEVIN WELLS Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	MNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2009
Decision Date	10/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review