BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Tester, Acoustic, Bone Quality

    PMA: P990039 · Supplement: S001 · Decision Jun 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Tester, Acoustic, Bone Quality
    Trade Name
    QUS-2 CALCANEAL ULTRASONOMETER
    PMA Number
    P990039
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NAN
    Generic Name
    Tester, acoustic, bone quality
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 19, 2003
    Date Received
    April 14, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.

    Classifications

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

    Product Code Device Name
    NAN Tester, Acoustic, Bone Quality