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510(k) Data Aggregation

    K Number
    K221008
    Device Name
    HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
    Manufacturer
    Shanghai Handy Medical Equipment Co., Ltd
    Date Cleared
    2022-06-22

    (78 days)

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

    Shanghai Handy Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HDR Sensor is is used for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
    Device Description
    Not Found
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