BEUDAMED
    FDA 510(k) Substantially Equivalent 🇺🇸 United States

    ELECTROCARDIOGRAPHS

    K Number: K972587 · Decision Aug 21, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    406

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    Basic Information

    Device Name
    ELECTROCARDIOGRAPHS
    K Number
    K972587
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dr. Lee Co., Ltd.
    Date Received
    July 11, 1997
    Decision Date
    August 21, 1998
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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