FDA 510(k) Application Details - K043018

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K043018
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	LARRY LEPLEY 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	11/02/2004
Decision Date	11/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review