Electrocardiograph

Electrocardiograph

Edan Instruments, Inc.

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

Pre-market Notification Details

Device IDK171942
510k NumberK171942
Device Name:Electrocardiograph
ClassificationElectrocardiograph
Applicant Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactAlice Yang
CorrespondentDoug Worth
Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale,  CA  94089
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-28
Decision Date2018-01-24
Summary:summary

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