FDA 510(k) Application Details - K102595

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K102595
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	MEDI-STIM ASA 435 RICE CREEK TERRACE NE FRIDLEY, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE G BUNDY 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	09/09/2010
Decision Date	12/27/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review