FDA 510(k) Application Details - K183574

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K183574
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff CF24 5HN GB Other 510(k) Applications for this Company
Contact	Steve Monks 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	12/21/2018
Decision Date	09/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review