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510(k) Data Aggregation

    K Number
    K092783
    Device Name
    DEBP
    Manufacturer
    ENKO LTD.
    Date Cleared
    2009-10-22

    (42 days)

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

    ENKO LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEBP is 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 Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breast or on both breasts at the same time. The Lansinoh DEBP can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to control cycle speed and vacuum level. The Lansinoh DEBP is capable of providing vacuum levels from 50 to 250 mmHg, with cycling rates up to 1.85 cycles per second.
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