MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS

Computer, Diagnostic, Pre-programmed, Single-function

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Modification To Computerized Catheterization Laboratory - Horizon 9000 Ws.

Pre-market Notification Details

Device IDK991775
510k NumberK991775
Device Name:MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot,  IL 76100
ContactKenneth Raichman
CorrespondentKenneth Raichman
MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot,  IL 76100
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-25
Decision Date1999-06-24
Summary:summary

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