ECG MODULE

Electrocardiograph

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Ecg Module.

Pre-market Notification Details

Device IDK862553
510k NumberK862553
Device Name:ECG MODULE
ClassificationElectrocardiograph
Applicant ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-03
Decision Date1986-11-07

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