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

    SONADA ULTRASOUND SYSTEM

    K Number: K993092 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    1
    Review Days
    211

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    Basic Information

    Device Name
    SONADA ULTRASOUND SYSTEM
    K Number
    K993092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sonovision Corp.
    Date Received
    September 16, 1999
    Decision Date
    April 14, 2000
    Product Code
    OXO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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