BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Applicator, Hyperthermia, Superficial, Rf/Microwave

    PMA: P880064 · Supplement: S002 · Decision Sep 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Applicator, Hyperthermia, Superficial, Rf/Microwave
    Trade Name
    HYPERTHERMIA SYSTEM 100 A
    PMA Number
    P880064
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LNC
    Generic Name
    Applicator, hyperthermia, superficial, rf/microwave
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 17, 1997
    Date Received
    July 15, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to enhance the heat focusing capabilities of the Microfocus 1000 Hyperthermia System.

    Classifications

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

    Product Code Device Name
    LNC Applicator, Hyperthermia, Superficial, Rf/Microwave