BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Controller, Closed-Loop, Blood-Pressure

    PMA: P860035 · Supplement: S005 · Decision Mar 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Controller, Closed-Loop, Blood-Pressure
    Trade Name
    TITRATOR{TM} MODEL 10K
    PMA Number
    P860035
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LSX
    Generic Name
    CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 1993
    Date Received
    March 25, 1992
    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
    LSX Controller, Closed-Loop, Blood-Pressure