FDA 510(k) Application Details - K131854

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K131854
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	OR-NIM MEDICAL LTD. 15 ATIR YEDA ST. KFAR SABA 4464312 IL Other 510(k) Applications for this Company
Contact	MICHA OESTEREICH Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2013
Decision Date	09/13/2013
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