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

    DYNAMIC ECG SYSTEM MODEL TLC5000

    K Number: K101273 · Decision Sep 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    12
    Review Days
    512

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    Basic Information

    Device Name
    DYNAMIC ECG SYSTEM MODEL TLC5000
    K Number
    K101273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    May 6, 2010
    Decision Date
    September 30, 2011
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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