FDA 510(k) Application Details - K043529

Device Classification Name	Medical Computers And Software   More FDA Info for this Device
510(K) Number	K043529
Device Name	Medical Computers And Software
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	Scott Thiel Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LNX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2004
Decision Date	04/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review