FDA 510(k) Application Details - K152930

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K152930
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	PERIMED AB DATAVAGEN 9A JARFALLA 17543 SE Other 510(k) Applications for this Company
Contact	MARIA PRANS LILJEVRET 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	10/05/2015
Decision Date	05/05/2016
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