FDA 510(k) Application Details - K983575

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K983575
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	DATASCOPE CORP. 580 WINTERS AVE. P.O. BOX 5 PARAMUS, NJ 07653 US Other 510(k) Applications for this Company
Contact	RUSSELL OLSEN 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	10/13/1998
Decision Date	05/13/1999
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	N
Expedited Review