FDA 510(k) Application Details - K974192

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K974192
Device Name	Computer, Diagnostic, Programmable
Applicant	BIOSENSOR CORP. 7001 EAST FISH LAKE RD. MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	STEVE SPRINGROSE 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	11/07/1997
Decision Date	03/04/1998
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