FDA 510(k) Application Details - K062043

Device Classification Name	Analyzer, Body Composition   More FDA Info for this Device
510(K) Number	K062043
Device Name	Analyzer, Body Composition
Applicant	OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	DONNA DJINOVICH 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	07/19/2006
Decision Date	11/07/2006
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