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510(k) Data Aggregation

    K Number
    K971543
    Device Name
    LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
    Manufacturer
    KAWECO GMBH
    Date Cleared
    1997-09-18

    (143 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAWECO GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.
    Device Description
    The Luxmatic 12-15 ISC Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm Hg and 220mm Hg) which includes a soft silicone tube and plastic tubing. An accessory kit includes overflow safety bottles, plastic breast shields and a collection cup. The device is battery and line-powered for 12V DC by a transformer or utilizes a 12V battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The overflow bottle contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the overflow. The pump can be used with Single Breast Pump Kit #281100 or Double Breast Pump Kit #281102. Dimensions are 7 X 12 X 7 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the overflow bottle, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. A bacterial filter may be used between the overflow bottle and the pump to prevent cross infection when more than one patient is using the pump. Bacterial filters should be changed regularly.
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