FDA 510(k) Application Details - K050395

Device Classification Name	Analyzer, Body Composition   More FDA Info for this Device
510(K) Number	K050395
Device Name	Analyzer, Body Composition
Applicant	IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS BRISBANE, QUEENSLAND 4113 AU Other 510(k) Applications for this Company
Contact	NEVELLI BERTWISTLE 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	02/16/2005
Decision Date	07/13/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review