FDA 510(k) Application Details - K111487

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K111487
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	NORAV MEDICAL CORP. INDUSTRIAL PARK 13, M.P. MISGAV MITZPE AVIV 20187 IL Other 510(k) Applications for this Company
Contact	BENNY ARAZY 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	05/31/2011
Decision Date	11/10/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review