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510(k) Data Aggregation

    K Number
    K040440
    Device Name
    HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
    Manufacturer
    HTTP HYPOTHERMIA THERAPY
    Date Cleared
    2004-04-27

    (67 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    HTTP HYPOTHERMIA THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HTTP system is intended to prevent and treat Hypothermia and provide warmth to cold or shivering patients. In addition, the HTTP system should be used whenever conditions exist that could cause patients to become cold/hypothermic. The HTTP system is indicated primarily for use in hospital, intensive care units, in operating, recovery and emergency rooms, in burns units and on medical/surgical floors. This system can be used with adults patients.
    Device Description
    The HTTP 2001 Controller and HTTP "Warm me" Blankets ("HTTP System") are designed to compensate for body heat loss before, during and after surgery, especially cavity surgery, and to compensate for the decrease in intensity of all internal processes due to narcosis. The system conducts direct heat to up to 4 blankets. HTTP Blankets are available in different shapes and sizes, including a modular kit of 4 blankets, e.g., one for each leg, the Full Chest, Half Chest, Back or Abdomen "Warm me" Blanket. The blankets are modular, pliable, disposable, insulated and isolated. HTTP System is suitable for all patient sizes. Each blanket is connected to a separate heater. A single blanket uses a single heater. The complete set of blankets applies heat to all sections of the patient's body that are not involved in the surgery. A computerized feedback loop controls patient core temperature in response to each patient's needs, as prescribed by the physician. The electrical output from Controller to blankets is only 6V. The system is powered by mains or by batteries.
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