FDA 510(k) Application Details - K032997

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K032997
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	MENNEN MEDICAL LTD. 4 HAYARDEN ST. YAVNE 81228 IL Other 510(k) Applications for this Company
Contact	EREZ NIMROD Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2003
Decision Date	10/15/2003
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