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

    MODEL IC 3000

    K Number: K827292 · Decision Jul 9, 1982
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    32

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    Basic Information

    Device Name
    MODEL IC 3000
    K Number
    K827292
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Xonics Medical Systems, Inc.
    Date Received
    June 7, 1982
    Decision Date
    July 9, 1982
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

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    K791298 DIAGNOSTIC ULTRASOUND SYSTEM
    K770693 X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC