HORIZON 2000 ARRHYTHMIA MONITORING OPTION

Detector And Alarm, Arrhythmia

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Arrhythmia Monitoring Option.

Pre-market Notification Details

Device IDK881273
510k NumberK881273
Device Name:HORIZON 2000 ARRHYTHMIA MONITORING OPTION
ClassificationDetector And Alarm, Arrhythmia
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactThomas Connelly
CorrespondentThomas Connelly
MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-25
Decision Date1988-07-12

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