FDA 510(k) Application Details - K042108

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K042108
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	NOVACOR 4, PASSAGE SAINT-ANTOINE RUEIL MALMAISON CEDEX 92508 FR Other 510(k) Applications for this Company
Contact	DOMINIQUE GRENIER Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2004
Decision Date	01/19/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review