BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3

    K Number: K012369 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
    K Number
    K012369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atys Medical
    Date Received
    July 26, 2001
    Decision Date
    August 10, 2001
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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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