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510(k) Data Aggregation

    K Number
    K013116
    Device Name
    DURQ/ QUALIDURA
    Date Cleared
    2002-01-18

    (122 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVER-SAFETY TECHNICAL SERVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ELECTRIC NOSE VACUUM IS designed to improve the disadvantages of the conventional rubber bulb type aspirators with poor suction power , unstable and hard to use. Now no more squeezing by hands or suction by mouth. It removes nasal mucus and fluids from baby's nostrils at home safely and easily.
    Device Description
    The device is an Electric Nose Vacuum (Aspirator) Model No : 02001. It is a powered pump aspiration device. It consists of a silicone rubber nozzle, a collection cup made of PC, a TPR button, and an enclosure made of ABS. The internal components include a Pump Body made of POM, a DC Motor (Mabuchi Motor Co., Ltd., Cat. No. : RE-280SA-2865) operating at 1.5 V - 4.5 V DC, and a DC Momentary Start Switch (Sweeta Products Corporation Cat. No. : PS-22F05) rated at 50 V DC 0.3 A. It is powered by a 4.5 V DC Power Supply and has a vacuum pressure of 0- 45 kpa.
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