FDA 510(k) Application Details - K993531

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K993531
Device Name	Detector And Alarm, Arrhythmia
Applicant	DATASCOPE CORP. 580 WINTERS AVE. PARAMUS, NJ 07652 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	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/1999
Decision Date	01/13/2000
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