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510(k) Data Aggregation

    K Number
    K240759
    Device Name
    REMEX-GR100
    Manufacturer
    Remedi Co., Ltd.
    Date Cleared
    2024-05-13

    (54 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remedi Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
    Device Description
    The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors.
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