FDA 510(k) Application Details - K012712

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K012712
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	NORAV MEDICAL LTD. 12505 58TH AVE. N. PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	STEVE SPRINGROSE 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	08/14/2001
Decision Date	05/08/2002
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