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

    750 SD ULTRASOUND SCANNER(MODIFICATION)

    K Number: K851901 · Decision Oct 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    176

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    Basic Information

    Device Name
    750 SD ULTRASOUND SCANNER(MODIFICATION)
    K Number
    K851901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ultrasonix, Inc.
    Date Received
    April 30, 1985
    Decision Date
    October 23, 1985
    Product Code
    DXK
    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
    DXK Echocardiograph

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