FDA 510(k) Application Details - K111730

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K111730
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	EM-TEC GMBH LERCHENBERG 20 FINNING 86923 DE Other 510(k) Applications for this Company
Contact	BERNHARD BRAND 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	06/20/2011
Decision Date	01/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review