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510(k) Data Aggregation

    K Number
    K222547
    Device Name
    Electric nasal aspirator
    Manufacturer
    Shenzhen XinLianFeng Technology CO.,LTD
    Date Cleared
    2022-10-20

    (58 days)

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

    Shenzhen XinLianFeng Technology CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Nasal Aspirator is 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 consists of main unit, and suction working together as one unit. The Electronic 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.
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