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

    OMNIGRAPH 4000(ELECTROCARDIOGRAPH)

    K Number: K852652 · Decision Nov 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
    K Number
    K852652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telemed Div.
    Date Received
    June 21, 1985
    Decision Date
    November 19, 1985
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by Telemed Div.

    K Number Device Name
    K880357 OMNIGRAPH 6000