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510(k) Data Aggregation

    K Number
    K131153
    Device Name
    EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
    Date Cleared
    2013-06-18

    (55 days)

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

    EVENFLO FEEDING INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
    Device Description
    The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pump that uses negative pressure to express milk from a lactating woman's breasts. A reciprocating vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels between 25 and 254 mmHg. The flange system is convertible between single and double pumping. Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience. The device can be powered by six "AA" batteries or the provided mains adapter.
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