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510(k) Data Aggregation

    K Number
    K100929
    Device Name
    UNIMOM ALLEGRO
    Manufacturer
    BLUE EGG CO
    Date Cleared
    2010-06-16

    (72 days)

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

    BLUE EGG CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Unimom Allegro is intended to express breast milk from the breast of a lactating woman.
    Device Description
    The Unimom Allegro electric breast pump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Unimom Allegro electric breast pump can operate off common batteries or off a DC POWER supply. The Unimom Allegro electric breast pump's drive unit employs a diaphragmtype vacuum pump, powered by a DC-motor, supervised by a microcontroller. Passing through an air tubing to breastshield, the vacuum is used to comfortably draw out the breast milk. This device is designed with 7 vacuum levels by pressing button.
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