FDA 510(k) Application Details - K984465

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K984465
Device Name	System, Ecg Analysis
Applicant	ERICH JAEGER B.V. REGULIERENING 11 NL-3981 LA BUNNIK NL-3981 NL Other 510(k) Applications for this Company
Contact	LEON DEN BAKKER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/1998
Decision Date	10/27/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review