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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Electric Nasal Aspirator (BC026, BC025, BC023)

    K Number: K250697 · Decision Apr 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    3
    Review Days
    47

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    Basic Information

    Device Name
    Electric Nasal Aspirator (BC026, BC025, BC023)
    K Number
    K250697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Kingboom Technology Co., Ltd.
    Date Received
    March 7, 2025
    Decision Date
    April 23, 2025
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Shenzhen Kingboom Technology Co., Ltd.

    K Number Device Name
    K260473 Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
    K260147 Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)