SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200

Electrocardiograph

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Smart Ecg Series Electrocardiograph, Models Se-3, Se-300a And 300b, Se-6, Se-600, Se-12, Se-12 Express And Se-1200.

Pre-market Notification Details

Device IDK091513
510k NumberK091513
Device Name:SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
ClassificationElectrocardiograph
Applicant EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
ContactWilliam Stern
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-05-22
Decision Date2009-07-24
Summary:summary

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