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

    CARDIOFAX Q ECG-8420A

    K Number: K922394 · Decision Mar 1, 1994
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    166
    Review Days
    650

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    Basic Information

    Device Name
    CARDIOFAX Q ECG-8420A
    K Number
    K922394
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    May 20, 1992
    Decision Date
    March 1, 1994
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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