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510(k) Data Aggregation

    K Number
    K172842

    Validate with FDA (Live)

    Device Name
    GCE704 Breast Pump
    Manufacturer
    Globalcare
    Date Cleared
    2018-06-18

    (272 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GCE704 Breast Pump is intended to express milk from the breasts of lactating women. The GCE704 Breast Pump is intended for a single user.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the GCE704 Breast Pump. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.

    Therefore, I cannot provide the requested information based on the given input.

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