FDA 510(k) Application Details - K950944

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K950944
Device Name	Computer, Diagnostic, Programmable
Applicant	BIOSENSOR CORP. 13755 FIRST AVENUE NORTH PLYMOUTH, MN 55441 US Other 510(k) Applications for this Company
Contact	DARREN D DERSHEM Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/1995
Decision Date	06/18/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review