BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Sonometer

    PMA: P990035 · Supplement: S006 · Decision Apr 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    SUNLIGHT OMNISENSE BONE SONOMETER
    PMA Number
    P990035
    Supplement Number
    S006
    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
    April 24, 2003
    Date Received
    November 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE MANAGEMENT MODULE "SUNLIGHT DESKTOP" (SLD). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNLIGHT DESKTOP, SLD AND IS AN ADD-ON TO THE OMNISENSE SOFTWARE THAT WILL FUNCTION AS AN INDEPENDENT APPLICATION. THE SUNLIGHT DESKTOP SOFTWARE ENABLES THE USER TO SHUT DOWN THE OMNISENSE SOFTWARE LEAVING THE PC SYSTEM OPERATING, SO THAT THE USER CAN THEN INITIATE ANY OTHER INSTALLED SOFTWARE (PER THE SOFTWARE MANUFACTURER REQUIREMENTS, WHICH WILL OPERATE INDEPENDENT OF THE OMNISENSE SOFTWARE. THIS WILL ALLOW THE USE OF SEVERAL DEVICES WITH THE CONTROL OF ONE PC.

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer