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

    PICKER ARTIS ULTRASOUND IMAGING SYS

    K Number: K842055 · Decision Aug 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    190
    Review Days
    94

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    Basic Information

    Device Name
    PICKER ARTIS ULTRASOUND IMAGING SYS
    K Number
    K842055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    May 22, 1984
    Decision Date
    August 24, 1984
    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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