FDA 510(k) Application Details - K042109

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K042109
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	NOVACOR FRANCE 4, PASSAGE SAINT ANTOINE RUEIL MALMAISON CEDEX 92508 FR Other 510(k) Applications for this Company
Contact	DOMINIQUE GRENIER 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	08/05/2004
Decision Date	03/09/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review