FDA 510(k) Application Details - K991775

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K991775
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	KENNETH RAICHMAN 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	05/25/1999
Decision Date	06/24/1999
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