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510(k) Data Aggregation

    K Number
    K240937
    Device Name
    AIM (N/A)
    Manufacturer
    Inventeur, LLC
    Date Cleared
    2024-12-16

    (255 days)

    Product Code
    CCK, CAT, MNK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inventeur, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.
    Device Description
    AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels. AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.
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