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

    HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS

    K Number: K022928 · Decision Dec 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    2
    Review Days
    98

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    Basic Information

    Device Name
    HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
    K Number
    K022928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hudson Diagnostic Imaging, LLC
    Date Received
    September 4, 2002
    Decision Date
    December 11, 2002
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Hudson Diagnostic Imaging, LLC

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    K040926 ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000