FDA 510(k) Application Details - K000190

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K000190
Device Name	Computer, Diagnostic, Programmable
Applicant	BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. DIAMOND BAR, CA 91765 US Other 510(k) Applications for this Company
Contact	SIGI CARON 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	01/13/2000
Decision Date	05/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review