FDA 510(k) Application Details - K091068

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K091068
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. MAHWAH, NJ 07430-0619 US Other 510(k) Applications for this Company
Contact	KATHLEEN KRAMER 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	04/14/2009
Decision Date	05/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review