BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Apex Locator (AL-Pex), Apex Locator (AL-Pex+)

    K Number: K232717 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
    K Number
    K232717
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changzhou Haili Medical Co., Ltd.
    Date Received
    September 5, 2023
    Decision Date
    December 22, 2023
    Product Code
    LQY
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LQY Locator, Root Apex

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