SE-601 SERIES ELECTROCARDIOGRAPH

Electrocardiograph

EDAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Se-601 Series Electrocardiograph.

Pre-market Notification Details

Device IDK093869
510k NumberK093869
Device Name:SE-601 SERIES ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
ContactWilliam Stern
CorrespondentWilliam Stern
EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers,  NY  10701
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-17
Decision Date2010-04-01
Summary:summary

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