BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Sonometer

    PMA: P990016 · Supplement: S002 · Decision Mar 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
    PMA Number
    P990016
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    MUA
    Generic Name
    Bone sonometer
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 28, 2002
    Date Received
    January 16, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE CUBACLINICAL DATA CONTROLLER (DATA CONTROLLER). THE DATA CONTROLLER IS A HAND-HELD CONTROL DEVICE THAT ENABLES THE USER TO OPERATE THE CUBACLINICAL WITHOUT THE COMPUTER AND THE SOFTWARE FOR DATA ANALYSIS. THE MODIFICATIONS TO THE BONE SONOMETER CONSIST OF THE INTEGRATION OF THE DATA CONTROLLER AND ASSOCIATED SOFTWARE, SIMPLE REPLACEMENT OF THE CUBACLINICAL SERIAL CONNECTOR, AND DATA CONTROLLER OPERATING INSTRUCTIONS. THE RESULTS ARE DISPLAYED ON AN LCD SCREEN DISPLAY AND THE PRINTOUT SHOWS A GRAPHICAL DISPLAY OF PATIENT DATA.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUA Bone Sonometer