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    FDA 510(k) Substantially Equivalent 🇰🇷 South Korea

    CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

    K Number: K011328 · Decision Nov 21, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    3
    Review Days
    204

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    Basic Information

    Device Name
    CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
    K Number
    K011328
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionet Company, Ltd.
    Date Received
    May 1, 2001
    Decision Date
    November 21, 2001
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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