BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Transducer, Ultrasonic, Obstetric

    PMA: P800016 · Supplement: S012 · Decision Mar 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Transducer, Ultrasonic, Obstetric
    Trade Name
    TENNANT(TM) & KELMAN(TM) TYPE II
    PMA Number
    P800016
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    HGL
    Generic Name
    Transducer, ultrasonic, obstetric
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 2, 1989
    Date Received
    May 17, 1988
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    HGL Transducer, Ultrasonic, Obstetric