HORIZON 2000 ST ANALYSIS OPTION

Electrocardiograph

MENNEN MEDICAL, INC.

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

Pre-market Notification Details

Device IDK903524
510k NumberK903524
Device Name:HORIZON 2000 ST ANALYSIS OPTION
ClassificationElectrocardiograph
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 CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-06
Decision Date1991-03-01

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