BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Applicator, Hyperthermia, Deep Heating, Ultrasound

    PMA: P880062 · Supplement: S002 · Decision Feb 13, 1997
    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
    S002
    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
    February 13, 1997
    Date Received
    December 16, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE COMPUTER SYSTEM AND REVISIONS TO THE OPERATOR'S MANUAL FOR THE SONOTHERM 1000.

    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