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510(k) Data Aggregation

    K Number
    K243138
    Device Name
    Geon (S2) Nasal Aspirator
    Manufacturer
    Geon Corporation
    Date Cleared
    2025-02-04

    (127 days)

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

    Geon Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.
    Device Description
    Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.
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    K Number
    K220126
    Device Name
    Geonic Nasal Aspirator, Geonic Nasal Cleaner
    Manufacturer
    Geon Corporation
    Date Cleared
    2023-02-02

    (380 days)

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

    Geon Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.
    Device Description
    Not Found
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    K Number
    K100563
    Device Name
    GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
    Manufacturer
    GEON CORPORATION
    Date Cleared
    2010-06-02

    (93 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an digital thermometers intended for the intermittent measurement of human body temperature either in oral, rectal and axillaries (underarm) , by consumers in the home for people of all ages.
    Device Description
    Geon Rapid Digital Thermometer, Model no.: MT-B117 ,MT-B127 ,MT-B130 ,MT-B132FA
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