HORIZON PACEMAKER DETECTION SOFTWARE

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 Pacemaker Detection Software.

Pre-market Notification Details

Device IDK913339
510k NumberK913339
Device Name:HORIZON PACEMAKER DETECTION SOFTWARE
ClassificationDetector And Alarm, Arrhythmia
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactRichard G Whitehead
CorrespondentRichard G Whitehead
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 Received1991-07-26
Decision Date1992-01-08

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