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510(k) Data Aggregation

    K Number
    K973501
    Device Name
    EXPRESSE AND PREMIER POWERED BREAST PUMPS
    Manufacturer
    AMEDA MEDIZINTECHNIK AG
    Date Cleared
    1997-12-11

    (86 days)

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

    AMEDA MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
    Device Description
    The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between <100 and 360 mbar. Another control knob adjusts the suction rhythm (cycle) to one of 4 settings from 30 to 60 cycles per minute. The difference between the Premier and Expresse are the special bottle holders on the Expresse for using Freezer bags. All other features are substantially equivalent (Software, size, suction capacity, control knobs, weight, noise level and power supply.)
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