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 Horizon 9000 Ws.

Pre-market Notification Details

Device IDK940415
510k NumberK940415
Device Name:HORIZON 9000 WS
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactRonald A Brandt
CorrespondentRonald A Brandt
MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-28
Decision Date1995-01-06

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