Electrocardiograph: SE-1202

Electrocardiograph

Edan Instruments, Inc

The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Electrocardiograph: Se-1202.

Pre-market Notification Details

Device IDK210140
510k NumberK210140
Device Name:Electrocardiograph: SE-1202
ClassificationElectrocardiograph
Applicant Edan Instruments, Inc #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactYing Dai
CorrespondentYing Dai
Edan Instruments, Inc #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-10-01

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