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510(k) Data Aggregation

    K Number
    K013116
    Device Name
    DURQ/ QUALIDURA
    Manufacturer
    EVER-SAFETY TECHNICAL SERVICE
    Date Cleared
    2002-01-18

    (122 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text focuses on the 510(k) summary for the Durq Electric Nose Vacuum (Aspirator) and does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is primarily an administrative submission to the FDA, detailing the device's classification, intended use, and materials for substantial equivalence.

    Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets them based on the provided text.

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