FDA 510(k) Application Details - K043564

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K043564
Device Name	Computer, Diagnostic, Programmable
Applicant	MENNEN MEDICAL LTD. 4 HA-YARDEN ST. P.O. BOX 102 YAVNE, REHOVOT 81228 IL Other 510(k) Applications for this Company
Contact	MICHA OESTEREICH 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	12/27/2004
Decision Date	01/27/2005
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