FDA 510(k) Application Details - K191388

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K191388
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Flosonics Medical (r/a 1929803 Ontario Corp.) 204-73 Elm Street Sudbury P3C 1R7 CA Other 510(k) Applications for this Company
Contact	Joe 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	05/24/2019
Decision Date	06/21/2019
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