FDA 510(k) Application Details - K200337

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K200337
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Flosonics Medical (r/a 1929803 Ontario Corp.) 325 Front St W, Fourth Floor, OneEleven Toronto M5V 2Y1 CA Other 510(k) Applications for this Company
Contact	Andrew Eibl 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	02/11/2020
Decision Date	03/24/2020
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	Y
Expedited Review