BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    PMA: P820088 · Supplement: S016 · Decision Oct 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Rf/Microwave Hyperthermia, Cancer Treatment
    Trade Name
    BSD-500 HYPERTHERMIA SYSTEM
    PMA Number
    P820088
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    LOC
    Generic Name
    System, rf/microwave hyperthermia, cancer treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 8, 2003
    Date Received
    April 21, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REPLACE THE COMPUTER AND MONITOR AND FOR THE MINOR UPGRADE FOR THERMOMETRY CALIBRATION METHOD.

    Classifications

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

    Product Code Device Name
    LOC System, Rf/Microwave Hyperthermia, Cancer Treatment