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510(k) Data Aggregation

    K Number
    K081932
    Device Name
    ENDEARE BREAST PUMP
    Manufacturer
    HYGEIA MEDICAL, INC.
    Date Cleared
    2009-01-22

    (199 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K875300,K950750,K973501
    Predicate For
    K190465
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women

    Device Description

    The product is a powered breast pump with accessories that is used to express and collect milk from the breasts of lactating women

    AI/ML Overview

    The provided text is a 510(k) summary for the EnDeare™ Breast Pump. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as it is a breast pump, not a diagnostic or AI-powered device.

    Therefore, I cannot provide the requested information in the format specified. The document primarily focuses on demonstrating substantial equivalence to predicate breast pumps for regulatory clearance, rather than presenting performance data against a set of acceptance criteria.

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