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

    ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

    K Number: K040926 · Decision Jun 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    2
    Review Days
    63

    Basic Information

    Device Name
    ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
    K Number
    K040926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HUDSON DIAGNOSTIC IMAGING LLC
    Date Received
    April 8, 2004
    Decision Date
    June 10, 2004
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by HUDSON DIAGNOSTIC IMAGING LLC

    K Number Device Name
    K022928 HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS