FDA 510(k) Application Details - K052154

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K052154
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	IWAO KOJIMA Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2005
Decision Date	09/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review