BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Applicator, Hyperthermia, Deep Heating, Ultrasound

    PMA: P880062 · Supplement: S001 · Decision Aug 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Applicator, Hyperthermia, Deep Heating, Ultrasound
    Trade Name
    SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
    PMA Number
    P880062
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    LNB
    Generic Name
    Applicator, hyperthermia, deep heating, ultrasound
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 23, 1990
    Date Received
    May 17, 1990
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LNB Applicator, Hyperthermia, Deep Heating, Ultrasound