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

    SMS-712NA

    K Number: K903085 · Decision Oct 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    146
    Review Days
    85

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    Basic Information

    Device Name
    SMS-712NA
    K Number
    K903085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1240
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    July 12, 1990
    Decision Date
    October 5, 1990
    Product Code
    GXW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXW Echoencephalograph

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