BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    PMA: P840015 · Supplement: S013 · Decision Dec 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Rf/Microwave Hyperthermia, Cancer Treatment
    Trade Name
    CLINI-THERM MARK I/IV
    PMA Number
    P840015
    Supplement Number
    S013
    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
    December 15, 1988
    Date Received
    August 30, 1988
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    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