FDA 510(k) Application Details - K050415

Device Classification Name	Monitor, Extracellular Fluid, Lymphedema, Extremity   More FDA Info for this Device
510(K) Number	K050415
Device Name	Monitor, Extracellular Fluid, Lymphedema, Extremity
Applicant	IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS BRISBANE, QUEENSLAND 4113 AU Other 510(k) Applications for this Company
Contact	NEVILLE BERTWISTLE Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	OBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2005
Decision Date	03/30/2007
Decision	SESK - SUBST EQUIV - KIT
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