FDA 510(k) Application Details - K140740

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K140740
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. ITHACA, NY 14850 US Other 510(k) Applications for this Company
Contact	DAVID KLEMENTOWSKI 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	03/25/2014
Decision Date	07/23/2015
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