FDA 510(k) Application Details - K972798

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K972798
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	SOMETEC, INC. 92 MONTVALE AVE., SUITE 3150 STONEHAM, MA 02180 US Other 510(k) Applications for this Company
Contact	JEAN-LUC BOULNOIS 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	07/28/1997
Decision Date	02/24/1998
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