FDA 510(k) Application Details - K011540

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K011540
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	DATASCOPE CORP. 800 MACARTHUR BLVD. MAHWAH, NJ 07430-0619 US Other 510(k) Applications for this Company
Contact	SUSAN E MANDY Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2001
Decision Date	02/06/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review