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510(k) Data Aggregation

    K Number
    K161532
    Device Name
    Philips Avent Comfort Single/Twin Electric Breast Pump
    Manufacturer
    Philips Consumer Lifestyle-Innovation Site Eindhoven
    Date Cleared
    2016-08-29

    (88 days)

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

    Philips Consumer Lifestyle-Innovation Site Eindhoven

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips Avent Comfort Single/Twin Electric Breast Pump is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user.
    Device Description
    The subject devices are electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage. The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.
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