FDA 510(k) Application Details - K973078

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K973078
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA MAHWAH, NJ 07430-2113 US Other 510(k) Applications for this Company
Contact	BRENDA M KELLY 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	08/18/1997
Decision Date	05/20/1999
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