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

    Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)

    K Number: K242028 · Decision Nov 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    2
    Review Days
    131

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    Basic Information

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

    K Number Device Name
    K231969 BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)