BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FUTUREMED ECG SYSTEM 500

    K Number: K862381 · Decision Jul 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    17
    Review Days
    23

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    Basic Information

    Device Name
    FUTUREMED ECG SYSTEM 500
    K Number
    K862381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    June 24, 1986
    Decision Date
    July 17, 1986
    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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