FDA 510(k) Application Details - K201114

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K201114
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Koven Technology, Inc. 477 N. Lindbergh Blvd., Ste.220 St. Louis, MO 63141 US Other 510(k) Applications for this Company
Contact	Heather Bell 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	04/27/2020
Decision Date	01/05/2021
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