BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Sonometer

    PMA: P990035 · Supplement: S003 · Decision May 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Bone Sonometer
    Trade Name
    SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
    PMA Number
    P990035
    Supplement Number
    S003
    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
    May 24, 2002
    Date Received
    August 10, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE MANUFACTURING CALIBRATION SOFTWARE BY ADDING A NEW SPECIFICATION AND TEST METHODS THAT LIMITS THE AMPLITUDES OF THE THREE DIFFERENT PROBES WHICH ARE USED FOR THE APPROVED MULTIPLE SKELETAL SITES TO LESS THAN 520MV AND NORMALIZES THE PROBES TO PREDEFINED VALUES OF APPROXIMATELY 400MV.

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer