Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250697
    Device Name
    Electric Nasal Aspirator (BC026, BC025, BC023)
    Manufacturer
    Shenzhen Kingboom Technology Co., Ltd
    Date Cleared
    2025-04-23

    (47 days)

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

    Shenzhen Kingboom Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electric 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
    Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric 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 external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. The differences between BC026, BC025, and BC023 are as follows: 1) BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels. 2) BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function. 3) BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature. 4) BC026 and BC023 have 4 buttons, BC025 has 2 buttons. 5) In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.
    Ask a Question

    Page 1 of 1