BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    AI-ECG Tracker

    K Number: K200036 · Decision Mar 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    2
    Review Days
    72

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    Basic Information

    Device Name
    AI-ECG Tracker
    K Number
    K200036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Carewell Electronics Co., Ltd.
    Date Received
    January 8, 2020
    Decision Date
    March 20, 2020
    Product Code
    DPS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPS Electrocardiograph

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    Other Clearances by Shenzhen Carewell Electronics Co., Ltd.

    K Number Device Name
    K113485 ELECTROCARDIOGRAPH