HORIZON 1100 CARDIAC MONITOR

Electrocardiograph

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 1100 Cardiac Monitor.

Pre-market Notification Details

Device IDK864843
510k NumberK864843
Device Name:HORIZON 1100 CARDIAC MONITOR
ClassificationElectrocardiograph
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactSpencer K Wende
CorrespondentSpencer K Wende
MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-10
Decision Date1987-03-16

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