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510(k) Data Aggregation

    K Number
    K001058
    Device Name
    AUDIOSCREENER OAE + ABR
    Manufacturer
    KEDLY, INC.
    Date Cleared
    2000-06-02

    (60 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEDLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000184
    Device Name
    AUDIOSCREENER OAE
    Manufacturer
    KEDLY, INC.
    Date Cleared
    2000-02-11

    (22 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEDLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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