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

    M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540

    K Number: K014191 · Decision Jan 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    107
    Review Days
    17

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    Basic Information

    Device Name
    M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
    K Number
    K014191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    December 21, 2001
    Decision Date
    January 7, 2002
    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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