FDA 510(k) Application Details - K081484

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K081484
Device Name	Computer, Diagnostic, Programmable
Applicant	MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	IFAT OREN 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	05/28/2008
Decision Date	06/20/2008
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