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510(k) Data Aggregation

    K Number
    K242028
    Device Name
    Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
    Manufacturer
    Dongguanshi Yiyingmei Technology Co., Ltd.
    Date Cleared
    2024-11-19

    (131 days)

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

    Dongguanshi Yiyingmei Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.
    Device Description
    The Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions.The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
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